FDA
The FDA is responsible for protecting the public health.
Header_fda_profilepage-header

What We Do

Fda-image-3

 

The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

FDA In Their Voices

Working at FDA

Fda-image-1

 

We are actively recruiting for mission-critical medical and science positions to strengthen our public health mission.

We are attending job fairs throughout the United States to promote available positions and recruit applicants.

Career Opportunities at FDA

Supervisory Consumer Safety Officer
Duties DutiesSummaryThis position is located in the Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Enforcement and Import Operations (OEIO), Division of Northern Border Imports, Northern Border Import Compliance Branch II. The salary listed in the vacancy announcement is at the base level. The geographical locality pay will be determined at the time of selection. Additional selections may be made within the same geographical area FDA-wide.ResponsibilitiesAs the Director of the Compliance Branch, participate in all phase of District program planning and policy formulation.Review and evaluate evidence and findings indicating a possible lack of compliance with laws and regulations.Assist State and local cooperative officials in the development of uniform legislation, codes and regulations.Advise cooperative officials on the interpretation of Federal laws, regulations, and enforcement policies, and provide consultation relative to joint regulatory approaches.Supervise all Compliance Branch employees (including support staff) and is responsible for technical and administrative work accomplished in the Branch.Answer inquiries for other Federal, State or local agencies, foreign missions, Industry, and importers regarding the interpretations of Agency-enforced laws and regulations, case studies, and enforcement policies.Plan, organize, and implement in cooperation with other field/district components, comprehensive industry education, training, and technical advice.Travel Required25% or less - You may be expected to travel for this position. Supervisory status Yes Promotion Potential 14 Job family (Series) Requirements Requirements Conditions of EmploymentCitizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement.Time-in-Grade Requirement: If you are applying as a current Federal employee, you must meet the time-in-grade requirements described in the Qualifications section, generally, 52-weeks of comparable experience at the next lowest grade.Certification of Accuracy: All information concerning qualification for employment is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection or appropriate disciplinary action.You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and time-in-grade qualifications attained by this date will be considered.One year of supervisory probationary may be required.Candidates must meet time-after-competitive appointment, time-in-grade (if applicable), qualification requirements, licensure requirements, performance requirements, citizenship and suitability requirements, and any other eligibility requirements. QualificationsIn order to qualify for Supervisory Consumer Safety Officer, 0696, at GS - 14, you must meet Time-in-Grade requirements by 05/07/2018. In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above. You must possess the basic requirements identified below to be considered eligible for the position. Transcripts must be provided with the application to validate that coursework requirements are met. Failure to submit all transcripts will be considered an incomplete application.The education must have been obtained at a college, university, or an accrediting body recognized by the Secretary, U.S. Department of Education at the time the degree was obtained. BASIC REQUIREMENT: Applicants must meet one of the following requirements. A bachelor's or graduate/higher level degree in quality assurance or a related degree that included at least 30 semester hours in one or a combination of the following: consumer laws, biological sciences, food science, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, legal investigations, law enforcement, or related scientific fields that provided knowledge directly related to consumer safety officer work. The 30 semester hours may include up to 8 semester hours in statistics, or course work that included the principles, theory, or practical application of computers or computer programming. OR Combination of education and experience--courses consisting of at least 30 semester hours in the fields of study described in paragraph A above, plus appropriate experience or additional education.In addition to meeting basic requirements for the Supervisory Consumer Safety Officer, GS-0696-14, you must meet the following specialized experience: One year of specialized experience equivalent to the GS-13 grade level in Federal service that demonstrates your ability and is directly related to the position being filled and has equipped the applicant with the particular knowledge, skills and abilities to perform the duties of the position, and that is typically in or related to the work of the position to be filled. Examples of specialized experience includes interpreting and analyzing the Food, Drug and Cosmetic Act and related Acts and regulations; planning, organizing, prioritizing, and directing technical, investigative and professional work. In addition, the applicant must demonstrate in his or her work experience or training that they possess, or have the potential to develop the qualities of successful supervision.TIME-IN-GRADE REQUIREMENT: GS-14; Applicants must have 52 weeks at the GS-13 grade level or higher.SUPERVISORY QUALIFICATION REQUIREMENT: The candidate chosen for this position must serve a one-year supervisory probationary period if s/he has not previously been a supervisor. Who May Apply: This is an internal announcement open to:-FDA/ORA employees on a career/career-conditional appointments in the competitive service; -PHS FDA/ORA Commissioned Officers; or -Displaced Federal employees requesting special priority selection consideration under the Career Transition Assistance Plan (CTAP) PHS FDA/ORA Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.You must submit documentation to verify your eligibility to apply for this vacancy. For most applicants, an SF-50 will be required. However, if you are applying based as a Veteran, person with a disability, or a displaced former employee, you will be required to provide other supporting documents as applicable. See the Required Documents section for more details.Education There is no education substitution at the GS-14 level. Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For more information about this requirement, please visit the .Additional informationADDITIONAL CONDITIONS OF EMPLOYMENT:Pre-employment physical required: No Drug testing required: No License required: Yes, Valid Driver's License Mobility agreement required: No Immunization required: No Bargaining Unit Position: No If you are serving, or have served in the last 5 years (from 05/07/2018) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. Financial disclosure statement, OGE-450, required: This position will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers.All requirements must be met by the closing date of this announcement (05/07/2018); only education and experience gained by this date will be considered. How You Will Be EvaluatedYou will be evaluated for this job based on how well you meet the qualifications above. Once the job opportunity announcement closes (at 11:59 pm ET on 05/07/2018), a review of your resume and supporting documentation will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your eligibility for this internal position. Eligible internal candidates will be referred to the hiring official for consideration.Please follow all instructions carefully. Errors or omissions may affect your eligibility.Basis of Rating: Merit Promotion Procedures for the Food and Drug Administration (FDA) will be used to rate and rank candidates. The category assignment is a measure of the degree in which your background matches the competencies required for this position. Qualified candidates will be ranked into one of two categories: Best Qualified or Qualified.Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You do not have to respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of the Competencies/KSA's.Organizational Awareness: Knows the organization's mission and functions, and how its social, political, and technical systems work and operates effectively within them; this includes the programs, policies, procedures, rules and regulations of the organization.Compliance Inspection: Knowledge of the guidelines, regulations, and procedures associated with compliance inquiries, including application of compliance rules and criteria and ability to make appropriate decisions and issue citations, fines, or orders.Technical Competence: Uses knowledge that is acquired through formal training and extensive on the job experience to perform one's job; works with, understands, and evaluates technical information related to the job; advises others on technical issues.Planning and Evaluating: Organizes work, sets priorities, and determines resource requirements; determines short-or long-term goals and strategies to achieve them; coordinates with other organizations or pats of the organization to accomplish goals; monitors progress and evaluates outcomes.Written Communication: Expresses facts and ideas in writing in a succinct and organized manner.Oral Communication: Expresses ideas and facts to individuals or groups effectively; makes clear and convincing oral presentations; listens to others; facilitates an open exchange of ideas.To review the application questionnaire, click the link below.Background checks and security clearanceSecurity clearance Required Documents Required DocumentsThe following documents are REQUIRED for this vacancy:Resume "Required" indicates that the above documents are required to determine your qualification for this vacancy. These documents are collected from ALL applicants and failing to provide any of these documents may result in your application being deemed incomplete or not qualified. Pay close attention to the list above to ensure you are providing all of the documentation we need to consider your application.RESUME REQUIREMENTS: The Federal Government has very specific requirements for the information that you must include in your resume. A resume for a Federal job will be much longer and more complete than the type of resume you may be familiar with from the private sector. If you have not written a Federal resume before, you may want to watch this on the , or read through a helpful on the .The following documents are ACCEPTED for this vacancy:Resume "Accepted" means that you will have the opportunity to submit these documents if they are applicable to you. Such documents include Veteran Preference or other special eligibility documentation, transcripts, or other optional documentation that helps us determine your eligibility. The above list of documents may not apply to all applicants.FDA EMPLOYEE DOCUMENTATION REQUIREMENTS FOR SF-50:Current and former Federal employees: You will need to submit a copy of your most recent SF-50 (Standard Form 50 - Notice of Personnel Action). To properly verify status eligibility, your SF-50 must show the following. If you do not submit an appropriate SF-50, we cannot verify your status eligibility! Full position title;Appointment type;Occupational series;Pay plan, series, grade, and step;Tenure code; andService Computation Date (SCD). If your current position SF-50 does not indicate you have competitive service status or does not reflect the pay plan and grade of the highest position you have held in the competitive service, in addition to your current SF-50, you must provide your previous SF-50s that provide the proof of competitive status and highest grade held on a permanent basis.PHS Commissioned Corps Officers: You will need to submit a copy of the latest personnel order. Displaced Federal employees who qualify for CTAP/ICTAP: If you are a former Federal employee who was displaced due to a Reduction-in-Force (RIF) or surplused by some other means, please submit a copy of the separation letter or RIF notice from your agency. To be selected under I/CTAP, you must still be found well-qualified for this position. Please see the OPM for more information. If you are relying on your education to meet qualification requirements: Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from . Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating. Benefits Benefits A career with the U.S. Government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. . Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time, or intermittent. Contact the hiring agency for more information on the specific benefits offered. How to Apply How to ApplyTo apply for positions with the Food & Drug Administration, you must have a USAJOBS account and be signed in to that account when you click "Apply Online". Additionally, you must provide a resume, any required supporting documentation listed on the announcement, and you must complete all assessment questionnaires BEFORE 11:59 pm Eastern Time on the closing date of this announcement,05/07/2018. We recommend that you start the application process early enough that you can complete and submit your application before this deadline. Please note that you cannot submit documentation or make changes to your application after the deadline, and in most cases, only experience and education obtained by this date will be considered. If you would like to learn how to use USAJOBS including: accessing and managing your account, adding saved documents, building a resume, or starting an application; we recommend you visit the USAJOBS How To site, and read up on any topic that you need help with. This site is located at: . Additionally, if you need technical assistance with USAJOBS (such as account issues) please visit the main USAJOBS Help site at: .The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are unfamiliar with Application Manager, and you encounter any difficulty with the site, we recommend that you first consult the Applicant Help Site at: . This help site contains step-by-step instructions for completing the application process, submitting documentation, and completing questionnaires, and should be very helpful to you! You are encouraged to apply online. Applying online will allow you to review and track the status of your application. The FDA will provide reasonable accommodation to applicants with disabilities who are not able to apply online. If you need a reasonable accommodation for any part of the application process, please contact the Applicant Help Desk. Decisions on granting a reasonable accommodation will be made on a case-by-case basis.If after reviewing the and help sites, you're not able to find the answer to your question or concern, or if you wish to request a reasonable accommodation, please contact the FDA Applicant Help Desk at 888-478-4340, or e-mail . The Applicant Help Desk is staffed between the hours of 7am and 6pm Eastern Time, Monday through Friday, except for government holidays. If you contact the Applicant Help Desk, please provide the following Vacancy Identification Number (VIN) 10199866 so that we may assist you faster.Agency contact informationFDA Applicant Help Desk FDA Applicant Help Desk PhoneEmailAddress Office of Regulatory Affairs 10903 New Hampshire Ave Silver Spring, MD US Next steps Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview. We strive to make selections within 45 days of the closing date of this announcement.You will application status updates via email and via USAJOBS as the process unfolds. Fair & Transparent Fair & Transparent The Federal hiring process is setup to be fair and transparent. Please read the following guidance. Equal Employment Opportunity Policy The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor. Reasonable Accommodation Policy Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application and hiring process should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis. A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits. Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when: An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job.An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace.An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events. You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis. Learn more about or Legal and regulatory guidance
Supervisory Consumer Safety Officer
Duties DutiesSummaryThis position is located in the Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Enforcement and Import Operations (OEIO), Division of Northern Border Imports, Northern Border Import Compliance Branch II. The salary listed in the vacancy announcement is at the base level. The geographical locality pay will be determined at the time of selection. Additional selections may be made within the same geographical area FDA-wide.ResponsibilitiesAs the Director of the Compliance Branch, participate in all phase of District program planning and policy formulation.Review and evaluate evidence and findings indicating a possible lack of compliance with laws and regulations.Assist State and local cooperative officials in the development of uniform legislation, codes and regulations.Advise cooperative officials on the interpretation of Federal laws, regulations, and enforcement policies, and provide consultation relative to joint regulatory approaches.Supervise all Compliance Branch employees (including support staff) and is responsible for technical and administrative work accomplished in the Branch.Answer inquiries for other Federal, State or local agencies, foreign missions, Industry, and importers regarding the interpretations of Agency-enforced laws and regulations, case studies, and enforcement policies.Plan, organize, and implement in cooperation with other field/district components, comprehensive industry education, training, and technical advice.Travel Required25% or less - You may be expected to travel for this position. Supervisory status Yes Promotion Potential 14 Job family (Series) Requirements Requirements Conditions of EmploymentCitizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement.Time-in-Grade Requirement: If you are applying as a current Federal employee, you must meet the time-in-grade requirements described in the Qualifications section, generally, 52-weeks of comparable experience at the next lowest grade.Certification of Accuracy: All information concerning qualification for employment is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection or appropriate disciplinary action.You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and time-in-grade qualifications attained by this date will be considered.One year of supervisory probationary may be required.Candidates must meet time-after-competitive appointment, time-in-grade (if applicable), qualification requirements, licensure requirements, performance requirements, citizenship and suitability requirements, and any other eligibility requirements. QualificationsIn order to qualify for Supervisory Consumer Safety Officer, 0696, at GS - 14, you must meet Time-in-Grade requirements by 05/07/2018. In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above. You must possess the basic requirements identified below to be considered eligible for the position. Transcripts must be provided with the application to validate that coursework requirements are met. Failure to submit all transcripts will be considered an incomplete application.The education must have been obtained at a college, university, or an accrediting body recognized by the Secretary, U.S. Department of Education at the time the degree was obtained. BASIC REQUIREMENT: Applicants must meet one of the following requirements. A bachelor's or graduate/higher level degree in quality assurance or a related degree that included at least 30 semester hours in one or a combination of the following: consumer laws, biological sciences, food science, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, legal investigations, law enforcement, or related scientific fields that provided knowledge directly related to consumer safety officer work. The 30 semester hours may include up to 8 semester hours in statistics, or course work that included the principles, theory, or practical application of computers or computer programming. OR Combination of education and experience--courses consisting of at least 30 semester hours in the fields of study described in paragraph A above, plus appropriate experience or additional education.In addition to meeting basic requirements for the Supervisory Consumer Safety Officer, GS-0696-14, you must meet the following specialized experience: One year of specialized experience equivalent to the GS-13 grade level in Federal service that demonstrates your ability and is directly related to the position being filled and has equipped the applicant with the particular knowledge, skills and abilities to perform the duties of the position, and that is typically in or related to the work of the position to be filled. Examples of specialized experience includes interpreting and analyzing the Food, Drug and Cosmetic Act and related Acts and regulations; planning, organizing, prioritizing, and directing technical, investigative and professional work. In addition, the applicant must demonstrate in his or her work experience or training that they possess, or have the potential to develop the qualities of successful supervision.TIME-IN-GRADE REQUIREMENT: GS-14; Applicants must have 52 weeks at the GS-13 grade level or higher.SUPERVISORY QUALIFICATION REQUIREMENT: The candidate chosen for this position must serve a one-year supervisory probationary period if s/he has not previously been a supervisor. Who May Apply: This is an internal announcement open to:-FDA/ORA employees on a career/career-conditional appointments in the competitive service; -PHS FDA/ORA Commissioned Officers; or -Displaced Federal employees requesting special priority selection consideration under the Career Transition Assistance Plan (CTAP) PHS FDA/ORA Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.You must submit documentation to verify your eligibility to apply for this vacancy. For most applicants, an SF-50 will be required. However, if you are applying based as a Veteran, person with a disability, or a displaced former employee, you will be required to provide other supporting documents as applicable. See the Required Documents section for more details.Education There is no education substitution at the GS-14 level. Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For more information about this requirement, please visit the .Additional informationADDITIONAL CONDITIONS OF EMPLOYMENT:Pre-employment physical required: No Drug testing required: No License required: Yes, Valid Driver's License Mobility agreement required: No Immunization required: No Bargaining Unit Position: No If you are serving, or have served in the last 5 years (from 05/07/2018) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. Financial disclosure statement, OGE-450, required: This position will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers.All requirements must be met by the closing date of this announcement (05/07/2018); only education and experience gained by this date will be considered. How You Will Be EvaluatedYou will be evaluated for this job based on how well you meet the qualifications above. Once the job opportunity announcement closes (at 11:59 pm ET on 05/07/2018), a review of your resume and supporting documentation will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your eligibility for this internal position. Eligible internal candidates will be referred to the hiring official for consideration.Please follow all instructions carefully. Errors or omissions may affect your eligibility.Basis of Rating: Merit Promotion Procedures for the Food and Drug Administration (FDA) will be used to rate and rank candidates. The category assignment is a measure of the degree in which your background matches the competencies required for this position. Qualified candidates will be ranked into one of two categories: Best Qualified or Qualified.Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You do not have to respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of the Competencies/KSA's.Organizational Awareness: Knows the organization's mission and functions, and how its social, political, and technical systems work and operates effectively within them; this includes the programs, policies, procedures, rules and regulations of the organization.Compliance Inspection: Knowledge of the guidelines, regulations, and procedures associated with compliance inquiries, including application of compliance rules and criteria and ability to make appropriate decisions and issue citations, fines, or orders.Technical Competence: Uses knowledge that is acquired through formal training and extensive on the job experience to perform one's job; works with, understands, and evaluates technical information related to the job; advises others on technical issues.Planning and Evaluating: Organizes work, sets priorities, and determines resource requirements; determines short-or long-term goals and strategies to achieve them; coordinates with other organizations or pats of the organization to accomplish goals; monitors progress and evaluates outcomes.Written Communication: Expresses facts and ideas in writing in a succinct and organized manner.Oral Communication: Expresses ideas and facts to individuals or groups effectively; makes clear and convincing oral presentations; listens to others; facilitates an open exchange of ideas.To review the application questionnaire, click the link below.Background checks and security clearanceSecurity clearance Required Documents Required DocumentsThe following documents are REQUIRED for this vacancy:Resume "Required" indicates that the above documents are required to determine your qualification for this vacancy. These documents are collected from ALL applicants and failing to provide any of these documents may result in your application being deemed incomplete or not qualified. Pay close attention to the list above to ensure you are providing all of the documentation we need to consider your application.RESUME REQUIREMENTS: The Federal Government has very specific requirements for the information that you must include in your resume. A resume for a Federal job will be much longer and more complete than the type of resume you may be familiar with from the private sector. If you have not written a Federal resume before, you may want to watch this on the , or read through a helpful on the .The following documents are ACCEPTED for this vacancy:Resume "Accepted" means that you will have the opportunity to submit these documents if they are applicable to you. Such documents include Veteran Preference or other special eligibility documentation, transcripts, or other optional documentation that helps us determine your eligibility. The above list of documents may not apply to all applicants.FDA EMPLOYEE DOCUMENTATION REQUIREMENTS FOR SF-50:Current and former Federal employees: You will need to submit a copy of your most recent SF-50 (Standard Form 50 - Notice of Personnel Action). To properly verify status eligibility, your SF-50 must show the following. If you do not submit an appropriate SF-50, we cannot verify your status eligibility! Full position title;Appointment type;Occupational series;Pay plan, series, grade, and step;Tenure code; andService Computation Date (SCD). If your current position SF-50 does not indicate you have competitive service status or does not reflect the pay plan and grade of the highest position you have held in the competitive service, in addition to your current SF-50, you must provide your previous SF-50s that provide the proof of competitive status and highest grade held on a permanent basis.PHS Commissioned Corps Officers: You will need to submit a copy of the latest personnel order. Displaced Federal employees who qualify for CTAP/ICTAP: If you are a former Federal employee who was displaced due to a Reduction-in-Force (RIF) or surplused by some other means, please submit a copy of the separation letter or RIF notice from your agency. To be selected under I/CTAP, you must still be found well-qualified for this position. Please see the OPM for more information. If you are relying on your education to meet qualification requirements: Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from . Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating. Benefits Benefits A career with the U.S. Government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. . Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time, or intermittent. Contact the hiring agency for more information on the specific benefits offered. How to Apply How to ApplyTo apply for positions with the Food & Drug Administration, you must have a USAJOBS account and be signed in to that account when you click "Apply Online". Additionally, you must provide a resume, any required supporting documentation listed on the announcement, and you must complete all assessment questionnaires BEFORE 11:59 pm Eastern Time on the closing date of this announcement,05/07/2018. We recommend that you start the application process early enough that you can complete and submit your application before this deadline. Please note that you cannot submit documentation or make changes to your application after the deadline, and in most cases, only experience and education obtained by this date will be considered. If you would like to learn how to use USAJOBS including: accessing and managing your account, adding saved documents, building a resume, or starting an application; we recommend you visit the USAJOBS How To site, and read up on any topic that you need help with. This site is located at: . Additionally, if you need technical assistance with USAJOBS (such as account issues) please visit the main USAJOBS Help site at: .The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are unfamiliar with Application Manager, and you encounter any difficulty with the site, we recommend that you first consult the Applicant Help Site at: . This help site contains step-by-step instructions for completing the application process, submitting documentation, and completing questionnaires, and should be very helpful to you! You are encouraged to apply online. Applying online will allow you to review and track the status of your application. The FDA will provide reasonable accommodation to applicants with disabilities who are not able to apply online. If you need a reasonable accommodation for any part of the application process, please contact the Applicant Help Desk. Decisions on granting a reasonable accommodation will be made on a case-by-case basis.If after reviewing the and help sites, you're not able to find the answer to your question or concern, or if you wish to request a reasonable accommodation, please contact the FDA Applicant Help Desk at 888-478-4340, or e-mail . The Applicant Help Desk is staffed between the hours of 7am and 6pm Eastern Time, Monday through Friday, except for government holidays. If you contact the Applicant Help Desk, please provide the following Vacancy Identification Number (VIN) 10199866 so that we may assist you faster.Agency contact informationFDA Applicant Help Desk FDA Applicant Help Desk PhoneEmailAddress Office of Regulatory Affairs 10903 New Hampshire Ave Silver Spring, MD US Next steps Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview. We strive to make selections within 45 days of the closing date of this announcement.You will application status updates via email and via USAJOBS as the process unfolds. Fair & Transparent Fair & Transparent The Federal hiring process is setup to be fair and transparent. Please read the following guidance. Equal Employment Opportunity Policy The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor. Reasonable Accommodation Policy Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application and hiring process should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis. A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits. Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when: An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job.An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace.An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events. You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis. Learn more about or Legal and regulatory guidance
Supervisory Consumer Safety Officer
Duties DutiesSummaryThis position serves as the first line supervisor over one or more investigatory units of Consumer Safety Officers. Position is in the Food and Drug Administration (FDA), Office of Global Regulatory Operations and Policy (OGROP), Office of Regulatory Affairs (ORA), Office of Human and Animal Food Operations-West (OHAFO-West) V and VI. This vacancy is open to current permanent employees of the Food and Drug Administration (FDA) only. Current FDA employees serving under a Schedule A appointment are eligible for consideration. Title 42 employees not eligible for reinstatement will not be considered. FDA Commissioned Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment. You must submit documentation to verify your eligibility to apply for this vacancy. For most applicants, your MOST recent SF-50 will be required. However, if you are applying as a FDA Commissioned Officer , you will be required to provide your PHS Personnel Orders.Additional selections may be made within the same geographical area FDA-wide.ResponsibilitiesPerform the administrative and personnel management functions relative to staff supervised.Establish guidelines and performance expectations for staff, which are clearly communicated through the formal employee performance management system.Develop and implement team-building techniques.Provide input on subordinate staff to next level management for consideration in strategic planning and budgets taking into account recommendations from team input.Assignments involve a combination of scientific and regulatory responsibilities including atypical inspection or investigative approaches to be applied to a wide variety of regulatory functions or intensive scientific evaluations.Travel Required25% or less - You may be expected to travel for this position. Supervisory status Yes Promotion Potential 13 Job family (Series) Requirements Requirements Conditions of EmploymentTime-in-Grade Requirement: If you are applying as a current Federal employee, you must meet the time-in-grade requirements described in the Qualifications section, generally, 52-weeks of comparable experience at the next lowest grade.Certification of Accuracy: All information concerning qualification for employment is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection or appropriate disciplinary action.You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and time-in-grade qualifications attained by this date will be considered.Candidates must meet time-after-competitive appointment, time-in-grade (if applicable), qualification requirements, licensure requirements, performance requirements, citizenship and suitability requirements, and any other eligibility requirements.One year supervisory probationary period may be required. Qualifications In order to qualify for Supervisory Consumer Safety Officer, 0696, at GS - 13, you must meet all qualification requirements by 05/10/2018.INDIVIDUAL OCCUPATIONAL REQUIREMENT: This position requires a degree or completion of specific courses in order to meet the basic education requirement. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. Your transcript(s) must clearly demonstrate the course(s) listed in the Basic Qualification requirement section. If the transcript(s) does not clearly demonstrate this, you must submit a copy of the course description and/or other documentation demonstrating that the courses are equivalent. Degree requirements must be met by the closing date of this job announcement and your transcript(s) submitted must reflect this. If you are selected for the position, an official transcript sent directly from your educational institution will be required for verification prior to appointment.Applicants must have successfully completed one of the following (A or B): A. Bachelor's or graduate/higher level degree in quality assurance or a related degree that included at least 30 semester hours in one or a combination of the following: consumer laws, biological sciences, food science, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, legal investigations, law enforcement, or related scientific fields that provided knowledge directly related to consumer safety officer work. The 30 semester hours may include up to 8 semester hours in statistics, or course work that included the principles, theory, or practical application of computers or computer programming; -OR B. Combination of education and experience--courses consisting of at least 30 semester hours in the fields of study described in paragraph A above, plus appropriate experience or additional education.GS-13: One year of specialized experience at least equivalent to the GS-12 in the Federal Service. SPECIALIZED EXPERIENCE: Experience directly related to the position to be filled which has equipped the applicant with the particular knowledge, skills and abilities to perform successfully the duties of the position and that is typically in or related to the work of the position to be filled, and can be demonstrated thorough knowledge of science, laws and regulations of the Agency. Specialized experience includes experience leading/coordinating a program segment that performs technical, investigative, and professional work; providing technical expertise, guidance and information to technical personnel; and/or planning work to be accomplished by others.TIME-IN-GRADE REQUIREMENT: Applicants must have 52 weeks at the GS-12 or higher.SUPERVISORY QUALIFICATION REQUIREMENT: The candidate chosen for this position must serve a one-year supervisory probationary period if s/he has not previously been a supervisor. In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above. EducationForeign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For more information about this requirement, please visit the .Additional informationADDITIONAL CONDITIONS OF EMPLOYMENT:Pre-employment physical required: NoDrug testing required: NoLicense required: Yes, valid drivers licenseMobility agreement required: NoImmunization required: NoBargaining Unit Position: NoIf you are serving, or have served in the last 5 years (from 05/10/2018) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. Financial disclosure statement, OGE-450, required: This position will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers.All requirements must be met by the closing date of this announcement (05/10/2018); only education and experience gained by this date will be considered. How You Will Be EvaluatedYou will be evaluated for this job based on how well you meet the qualifications above. Once the job opportunity announcement closes (at 11:59 pm ET on 05/10/2018), a review of your resume and supporting documentation will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your eligibility for this internal position. Eligible internal candidates will be referred to the hiring official for consideration.Please follow all instructions carefully. Errors or omissions may affect your eligibility.Basis of Rating: Merit Promotion Procedures for the Food and Drug Administration (FDA) will be used to rate and rank candidates. The category assignment is a measure of the degree in which your background matches the competencies required for this position. Qualified candidates will be ranked into one of two categories: Best Qualified or Qualified.Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You do not have to respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of the Competencies/KSA's.Organizational AwarenessLeadershipPlanning and Evaluating, Problem SolvingOral and Written CommunicationTo review the application questionnaire, click the link below.Background checks and security clearanceSecurity clearance Required Documents Required DocumentsThe following documents are REQUIRED for this vacancy:Resume "Required" indicates that the above documents are required to determine your qualification for this vacancy. These documents are collected from ALL applicants and failing to provide any of these documents may result in your application being deemed incomplete or not qualified. Pay close attention to the list above to ensure you are providing all of the documentation we need to consider your application.RESUME REQUIREMENTS: The Federal Government has very specific requirements for the information that you must include in your resume. A resume for a Federal job will be much longer and more complete than the type of resume you may be familiar with from the private sector. If you have not written a Federal resume before, you may want to watch this on the , or read through a helpful on the .The following documents are ACCEPTED for this vacancy:Cover LetterPHS OrdersResumeSF-50Transcript "Accepted" means that you will have the opportunity to submit these documents if they are applicable to you. Such documents include Veteran Preference or other special eligibility documentation, transcripts, or other optional documentation that helps us determine your eligibility. The above list of documents may not apply to all applicants.FDA EMPLOYEE DOCUMENTATION REQUIREMENTS FOR SF-50:Current and former Federal employees: You will need to submit a copy of your most recent SF-50 (Standard Form 50 - Notice of Personnel Action). To properly verify status eligibility, your SF-50 must show the following. If you do not submit an appropriate SF-50, we cannot verify your status eligibility. Full position title;Appointment type;Occupational series;Pay plan, series, grade, and step;Tenure code; andService Computation Date (SCD). If your current position SF-50 does not indicate you have competitive service status or does not reflect the pay plan and grade of the highest position you have held in the competitive service, in addition to your current SF-50, you must provide your previous SF-50s that provide the proof of competitive status and highest grade held on a permanent basis.Displaced Federal employees who qualify for CTAP/ICTAP: If you are a former Federal employee who was displaced due to a Reduction-in-Force (RIF) or surplused by some other means, please submit a copy of the separation letter or RIF notice from your agency. To be selected under I/CTAP, you must still be found well-qualified for this position. Please see the OPM for more information. If you are relying on your education to meet qualification requirements: Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from . Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating. Benefits Benefits A career with the U.S. Government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. . Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time, or intermittent. Contact the hiring agency for more information on the specific benefits offered. How to Apply How to ApplyTo apply for positions with the Food & Drug Administration, you must have a USAJOBS account and be signed in to that account when you click "Apply Online". Additionally, you must provide a resume, any required supporting documentation listed on the announcement, and you must complete all assessment questionnaires BEFORE 11:59 pm Eastern Time on the closing date of this announcement,05/10/2018. We recommend that you start the application process early enough that you can complete and submit your application before this deadline. Please note that you cannot submit documentation or make changes to your application after the deadline, and in most cases, only experience and education obtained by this date will be considered. If you would like to learn how to use USAJOBS including: accessing and managing your account, adding saved documents, building a resume, or starting an application; we recommend you visit the USAJOBS How To site, and read up on any topic that you need help with. This site is located at: . Additionally, if you need technical assistance with USAJOBS (such as account issues) please visit the main USAJOBS Help site at: .The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are unfamiliar with Application Manager, and you encounter any difficulty with the site, we recommend that you first consult the Applicant Help Site at: . This help site contains step-by-step instructions for completing the application process, submitting documentation, and completing questionnaires, and should be very helpful to you! You are encouraged to apply online. Applying online will allow you to review and track the status of your application. The FDA will provide reasonable accommodation to applicants with disabilities who are not able to apply online. If you need a reasonable accommodation for any part of the application process, please contact the Applicant Help Desk. Decisions on granting a reasonable accommodation will be made on a case-by-case basis.If after reviewing the and help sites, you're not able to find the answer to your question or concern, or if you wish to request a reasonable accommodation, please contact the FDA Applicant Help Desk at 888-478-4340, or e-mail . The Applicant Help Desk is staffed between the hours of 7am and 6pm Eastern Time, Monday through Friday, except for government holidays. If you contact the Applicant Help Desk, please provide the following Vacancy Identification Number (VIN) 10196827 so that we may assist you faster.Agency contact informationFDA Applicant Help Desk FDA Applicant Help Desk PhoneEmailAddress Office of Regulatory Affairs 10903 New Hampshire Ave Silver Spring, MD US Next steps Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview. We strive to make selections within 45 days of the closing date of this announcement.You will application status updates via email and via USAJOBS as the process unfolds. Fair & Transparent Fair & Transparent The Federal hiring process is setup to be fair and transparent. Please read the following guidance. Equal Employment Opportunity Policy The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor. Reasonable Accommodation Policy Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application and hiring process should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis. A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits. Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when: An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job.An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace.An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events. You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis. Learn more about or Legal and regulatory guidance
Supervisory Consumer Safety Officer
Duties DutiesSummaryThis position serves as the first line supervisor over one or more investigatory units of Consumer Safety Officers. Position is in the Food and Drug Administration (FDA), Office of Global Regulatory Operations and Policy (OGROP), Office of Regulatory Affairs (ORA), Office of Human and Animal Food Operations-West (OHAFO-West) V and VI. This vacancy is open to current permanent employees of the Food and Drug Administration (FDA) only. Current FDA employees serving under a Schedule A appointment are eligible for consideration. Title 42 employees not eligible for reinstatement will not be considered. FDA Commissioned Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment. You must submit documentation to verify your eligibility to apply for this vacancy. For most applicants, your MOST recent SF-50 will be required. However, if you are applying as a FDA Commissioned Officer , you will be required to provide your PHS Personnel Orders.Additional selections may be made within the same geographical area FDA-wide.ResponsibilitiesPerform the administrative and personnel management functions relative to staff supervised.Establish guidelines and performance expectations for staff, which are clearly communicated through the formal employee performance management system.Develop and implement team-building techniques.Provide input on subordinate staff to next level management for consideration in strategic planning and budgets taking into account recommendations from team input.Assignments involve a combination of scientific and regulatory responsibilities including atypical inspection or investigative approaches to be applied to a wide variety of regulatory functions or intensive scientific evaluations.Travel Required25% or less - You may be expected to travel for this position. Supervisory status Yes Promotion Potential 13 Job family (Series) Requirements Requirements Conditions of EmploymentTime-in-Grade Requirement: If you are applying as a current Federal employee, you must meet the time-in-grade requirements described in the Qualifications section, generally, 52-weeks of comparable experience at the next lowest grade.Certification of Accuracy: All information concerning qualification for employment is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection or appropriate disciplinary action.You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and time-in-grade qualifications attained by this date will be considered.Candidates must meet time-after-competitive appointment, time-in-grade (if applicable), qualification requirements, licensure requirements, performance requirements, citizenship and suitability requirements, and any other eligibility requirements.One year supervisory probationary period may be required. Qualifications In order to qualify for Supervisory Consumer Safety Officer, 0696, at GS - 13, you must meet all qualification requirements by 05/10/2018.INDIVIDUAL OCCUPATIONAL REQUIREMENT: This position requires a degree or completion of specific courses in order to meet the basic education requirement. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. Your transcript(s) must clearly demonstrate the course(s) listed in the Basic Qualification requirement section. If the transcript(s) does not clearly demonstrate this, you must submit a copy of the course description and/or other documentation demonstrating that the courses are equivalent. Degree requirements must be met by the closing date of this job announcement and your transcript(s) submitted must reflect this. If you are selected for the position, an official transcript sent directly from your educational institution will be required for verification prior to appointment.Applicants must have successfully completed one of the following (A or B): A. Bachelor's or graduate/higher level degree in quality assurance or a related degree that included at least 30 semester hours in one or a combination of the following: consumer laws, biological sciences, food science, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, legal investigations, law enforcement, or related scientific fields that provided knowledge directly related to consumer safety officer work. The 30 semester hours may include up to 8 semester hours in statistics, or course work that included the principles, theory, or practical application of computers or computer programming; -OR B. Combination of education and experience--courses consisting of at least 30 semester hours in the fields of study described in paragraph A above, plus appropriate experience or additional education.GS-13: One year of specialized experience at least equivalent to the GS-12 in the Federal Service. SPECIALIZED EXPERIENCE: Experience directly related to the position to be filled which has equipped the applicant with the particular knowledge, skills and abilities to perform successfully the duties of the position and that is typically in or related to the work of the position to be filled, and can be demonstrated thorough knowledge of science, laws and regulations of the Agency. Specialized experience includes experience leading/coordinating a program segment that performs technical, investigative, and professional work; providing technical expertise, guidance and information to technical personnel; and/or planning work to be accomplished by others.TIME-IN-GRADE REQUIREMENT: Applicants must have 52 weeks at the GS-12 or higher.SUPERVISORY QUALIFICATION REQUIREMENT: The candidate chosen for this position must serve a one-year supervisory probationary period if s/he has not previously been a supervisor. In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above. EducationForeign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For more information about this requirement, please visit the .Additional informationADDITIONAL CONDITIONS OF EMPLOYMENT:Pre-employment physical required: NoDrug testing required: NoLicense required: Yes, valid drivers licenseMobility agreement required: NoImmunization required: NoBargaining Unit Position: NoIf you are serving, or have served in the last 5 years (from 05/10/2018) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. Financial disclosure statement, OGE-450, required: This position will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers.All requirements must be met by the closing date of this announcement (05/10/2018); only education and experience gained by this date will be considered. How You Will Be EvaluatedYou will be evaluated for this job based on how well you meet the qualifications above. Once the job opportunity announcement closes (at 11:59 pm ET on 05/10/2018), a review of your resume and supporting documentation will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your eligibility for this internal position. Eligible internal candidates will be referred to the hiring official for consideration.Please follow all instructions carefully. Errors or omissions may affect your eligibility.Basis of Rating: Merit Promotion Procedures for the Food and Drug Administration (FDA) will be used to rate and rank candidates. The category assignment is a measure of the degree in which your background matches the competencies required for this position. Qualified candidates will be ranked into one of two categories: Best Qualified or Qualified.Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You do not have to respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of the Competencies/KSA's.Organizational AwarenessLeadershipPlanning and Evaluating, Problem SolvingOral and Written CommunicationTo review the application questionnaire, click the link below.Background checks and security clearanceSecurity clearance Required Documents Required DocumentsThe following documents are REQUIRED for this vacancy:Resume "Required" indicates that the above documents are required to determine your qualification for this vacancy. These documents are collected from ALL applicants and failing to provide any of these documents may result in your application being deemed incomplete or not qualified. Pay close attention to the list above to ensure you are providing all of the documentation we need to consider your application.RESUME REQUIREMENTS: The Federal Government has very specific requirements for the information that you must include in your resume. A resume for a Federal job will be much longer and more complete than the type of resume you may be familiar with from the private sector. If you have not written a Federal resume before, you may want to watch this on the , or read through a helpful on the .The following documents are ACCEPTED for this vacancy:Cover LetterPHS OrdersResumeSF-50Transcript "Accepted" means that you will have the opportunity to submit these documents if they are applicable to you. Such documents include Veteran Preference or other special eligibility documentation, transcripts, or other optional documentation that helps us determine your eligibility. The above list of documents may not apply to all applicants.FDA EMPLOYEE DOCUMENTATION REQUIREMENTS FOR SF-50:Current and former Federal employees: You will need to submit a copy of your most recent SF-50 (Standard Form 50 - Notice of Personnel Action). To properly verify status eligibility, your SF-50 must show the following. If you do not submit an appropriate SF-50, we cannot verify your status eligibility. Full position title;Appointment type;Occupational series;Pay plan, series, grade, and step;Tenure code; andService Computation Date (SCD). If your current position SF-50 does not indicate you have competitive service status or does not reflect the pay plan and grade of the highest position you have held in the competitive service, in addition to your current SF-50, you must provide your previous SF-50s that provide the proof of competitive status and highest grade held on a permanent basis.Displaced Federal employees who qualify for CTAP/ICTAP: If you are a former Federal employee who was displaced due to a Reduction-in-Force (RIF) or surplused by some other means, please submit a copy of the separation letter or RIF notice from your agency. To be selected under I/CTAP, you must still be found well-qualified for this position. Please see the OPM for more information. If you are relying on your education to meet qualification requirements: Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from . Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating. Benefits Benefits A career with the U.S. Government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. . Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time, or intermittent. Contact the hiring agency for more information on the specific benefits offered. How to Apply How to ApplyTo apply for positions with the Food & Drug Administration, you must have a USAJOBS account and be signed in to that account when you click "Apply Online". Additionally, you must provide a resume, any required supporting documentation listed on the announcement, and you must complete all assessment questionnaires BEFORE 11:59 pm Eastern Time on the closing date of this announcement,05/10/2018. We recommend that you start the application process early enough that you can complete and submit your application before this deadline. Please note that you cannot submit documentation or make changes to your application after the deadline, and in most cases, only experience and education obtained by this date will be considered. If you would like to learn how to use USAJOBS including: accessing and managing your account, adding saved documents, building a resume, or starting an application; we recommend you visit the USAJOBS How To site, and read up on any topic that you need help with. This site is located at: . Additionally, if you need technical assistance with USAJOBS (such as account issues) please visit the main USAJOBS Help site at: .The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are unfamiliar with Application Manager, and you encounter any difficulty with the site, we recommend that you first consult the Applicant Help Site at: . This help site contains step-by-step instructions for completing the application process, submitting documentation, and completing questionnaires, and should be very helpful to you! You are encouraged to apply online. Applying online will allow you to review and track the status of your application. The FDA will provide reasonable accommodation to applicants with disabilities who are not able to apply online. If you need a reasonable accommodation for any part of the application process, please contact the Applicant Help Desk. Decisions on granting a reasonable accommodation will be made on a case-by-case basis.If after reviewing the and help sites, you're not able to find the answer to your question or concern, or if you wish to request a reasonable accommodation, please contact the FDA Applicant Help Desk at 888-478-4340, or e-mail . The Applicant Help Desk is staffed between the hours of 7am and 6pm Eastern Time, Monday through Friday, except for government holidays. If you contact the Applicant Help Desk, please provide the following Vacancy Identification Number (VIN) 10196827 so that we may assist you faster.Agency contact informationFDA Applicant Help Desk FDA Applicant Help Desk PhoneEmailAddress Office of Regulatory Affairs 10903 New Hampshire Ave Silver Spring, MD US Next steps Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview. We strive to make selections within 45 days of the closing date of this announcement.You will application status updates via email and via USAJOBS as the process unfolds. Fair & Transparent Fair & Transparent The Federal hiring process is setup to be fair and transparent. Please read the following guidance. Equal Employment Opportunity Policy The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor. Reasonable Accommodation Policy Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application and hiring process should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis. A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits. Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when: An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job.An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace.An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events. You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis. Learn more about or Legal and regulatory guidance
Quality Assurance Specialist
Duties DutiesSummaryJoin the Center for Veterinary Medicine (CVM) in the protection of human and animal health. At CVM, we are responsible for regulating food, food additives, drugs, and devices for millions of pets and food-producing animals. As a high performance organization, we strive for leadership, innovation, and excellence across all operations, occupations, and grade levels. about why CVM is the best fit for your talents. Begin your career with CVM today.Who May Apply: Federal employees with career or career-conditional appointments in the competitive service; former Federal employees with reinstatement eligibility based on previous career or career-conditional appointments; displaced Federal employees requesting special priority selection consideration under the Career Transition Assistance Plan (CTAP) and the Interagency Career Transition Assistance Plan (ICTAP); veterans eligible under provisions of VEOA who are preference eligibles or who have been separated under honorable conditions after 3 years or more of continuous active service; Military Spouses; PHS Commissioned Corps Officers; individuals eligible for VRA appointments (at the GS-11 and below grade levels); and individuals with disabilities. . This vacancy is also being announced concurrently with vacancy announcement FDA-CVM-18-DE-10193889 under delegated examining procedures. Please review that announcement to see if you are eligible for consideration under delegated examining procedures. Applicants must apply separately for each announcement in order to be considered under both.Additional selections may be made within the same geographical area FDA-wide.ResponsibilitiesThis position is located in the FDA, Office of Foods and Veterinary Medicine, Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE), Division of Business Information Science and Management in Rockville, Maryland.ONADE's primary responsibility is to review information submitted by drug sponsors who want approval to market animal drugs.ONADE accomplishes its mission by ensuring four critical review standards are met before a drug is approved for marketing.First, animal drugs must be safe; safe for the animal, safe for the humans consuming food derived from treated animals and safe for the user or the person administering the drug.Second, animal drugs must be effective for their intended uses.Third, animal drugs must be quality manufactured in accordance with current Good Manufacturing Practice regulations.Fourth, animal drugs must be properly labeled to accurately inform the end-user on how to use the drug safely and effectively.In addition, ONADE considers the impact of an animal drug on the environment during the review process.As a Quality Assurance Specialist in ONADE, you will:Develop plans and projects for achieving and maintaining quality assurance under Good Laboratory Practice Regulations and Good Clinical Practice Guidance.You will conduct quality assurance study reviews of new animal drug applications and drug approval packages to ensure quality and compliance with CVM/FDA regulatory requirements.You will also provide advice and guidance on Good Laboratory Practice Regulations, Good Clinical Practice Guidance, Standard Operating Procedures, Food, Drug and Cosmetic Act, and Title 21 of the Federal Regulations.Travel RequiredNot required Supervisory status No Promotion Potential 13 Job family (Series) Requirements Requirements Conditions of EmploymentCitizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement.Time-in-Grade Requirement: If you are applying as a current Federal employee, you must meet the time-in-grade requirements described in the Qualifications section, generally, 52-weeks of comparable experience at the next lowest grade.Selective Service Registration: All males born on, or after, 12/31/1959, must be registered with the Selective Service OR have an approved exemption.FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the problem.Security and Background Requirements: Appointment will require passing a background investigation. Not meeting this requirement may be grounds for personnel action. If hired, you may be subject to a background check at a later time.Certification of Accuracy: All information concerning qualification for employment is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection or appropriate disciplinary action.Direct Deposit: You will be required to have your federal salary payments electronically deposited into an account with a financial institution of your choice.You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and qualifications attained by this date will be considered. QualificationsIn order to qualify for Quality Assurance Specialist, 1910, at GS - 12, you must meet Time-in-Grade requirements by 05/09/2018. Selective Placement Factor: You must possess one year of regulatory quality assurance experience conducting quality assurance reviews of clinical and/or nonclinical laboratory studies in support of drug approvals to determine compliance with regulatory requirements.ANDBasic Requirements You must possess a degree with a major study of quality assurance, statistics, mathematics, production management, industrial management, computer science, engineering, engineering technology, physical sciences, textiles, or other fields related to the position.OR Possess one year experience that demonstrates a practical knowledge in monitoring, controlling or maintaining the quality of products or services in quality assurance, procurement, inspection, production or related areas. Examples includes: Experience reviewing production activities and capabilities in light of contract quality requirements.Reviewing written quality or inspection procedures for adequacy, and evaluating the implementation and effectiveness of quality/inspection systems, including sampling plans;Analyzing quality data to detect unsatisfactory trends or weaknesses in the quality/inspection system.Verifying by test or inspection, using sampling inspection or intensive product inspection techniques that products comply with requirements prior to acceptance.Identifying inadequacies and requesting corrective action;Computing data, summarizing results, and preparing reports or charts depicting pertinent relationships using statistical methods.Investigating customer complaints and deficiency reports, and providing identification of causes to appropriate authorities.Reading, interpreting, and applying technical data such as blueprints, engineering drawings, product specifications, or technical manuals;Reviewing and evaluating supply systems operations and procedures through periodic audits and surveillance inspection.ANDMinimum Qualifications for GS-12 You must possess one year of specialized experience equivalent to at least the GS-11 level in the Federal service. Experience includes:developing, implementing, and/or executing programs, plans, or projects to achieve and maintain quality assurance under Good Laboratory Practice Regulations and/or Good Laboratory Practice Guidance; performing quality assurance reviews/assessments of drug study reports to ensure compliance with Good Laboratory Practice Regulations and/or Good Laboratory Practice Guidance; and providing guidance on laws, regulations, and guidelines governing quality assurance programs/plans in a regulatory environment. This experience must be reflected in your resume. Volunteer experience can also be used as qualifying experience. In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above.PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.You must submit documentation to verify your eligibility to apply for this vacancy. For most applicants, an SF-50 will be required. However, if you are applying based as a Veteran, person with a disability, or a displaced former employee, you will be required to provide other supporting documents as applicable. See the Required Documents section for more details.EducationForeign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For more information about this requirement, please visit the .Additional informationADDITIONAL CONDITIONS OF EMPLOYMENT:Pre-employment physical required: NoDrug testing required: NoLicense required: NoMobility agreement required: NoImmunization required: NoBargaining Unit Position: YesIncentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.If you are serving, or have served in the last 5 years (from 05/09/2018) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. Veteran's Preference: If you plan to apply for any kind of Veteran Preference, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. .Schedule A: If you plan to apply under Schedule A based on a disability, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. Inter-agency and Career Transition Assistance Programs: If you are a displaced Federal employee and plan to apply under CTAP or ICTAP, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. Financial disclosure statement, OGE-450, required: NoAs part of a Government-wide initiative to increase the efficiencies in the use of Federal real estate by creating new alternative office solutions, ONADE operates in a hoteling work environment. Hoteling is an arrangement where employees reserve non-dedicated, non-permanent workspace at the duty station on an as needed basis and as required (when in person attendance is deemed important and regardless of need, no less than 2 days per pay period). ONADE provides the basic technology needed to effectively work in the Rockville office and in a teleworking location (e.g., laptop, monitors, webcam). Hoteling, along with a strong telework program and strong electronic communication and workflow tools, affords employees in ONADE the flexibility to balance work/life demands while contributing to our high performing organization.All requirements must be met by the closing date of this announcement (05/09/2018); only education and experience gained by this date will be considered. How You Will Be EvaluatedYou will be evaluated for this job based on how well you meet the qualifications above. Once the job opportunity announcement closes (at 11:59 pm ET on 05/09/2018), a review of your resume and supporting documentation will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your eligibility for Federal employment, and then whether or not you are qualified for this particular position. If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible or your score may be adjusted to more accurately reflect your skills and abilities.Please follow all instructions carefully. Errors or omissions may affect your eligibility.Interview Process: Structured interviews; may be asked scenario-based interview questions concerning core competencies. Method/tools used to evaluate applicants: work samples, conducting a presentation, reference checks, tests may be used.Basis of Rating: Merit Promotion Procedures for the Food and Drug Administration (FDA) will be used to rate and rank candidates. The category assignment is a measure of the degree in which your background matches the competencies required for this position. Qualified candidates will be ranked into one of two categories: Best Qualified or Qualified.Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You need not respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of these Competencies.Quality Assurance Program ManagementRegulatory Compliance ManagementTechnical AdvisorTo review the application questionnaire, click the link below.Background checks and security clearanceSecurity clearance Required Documents Required DocumentsThe following documents are REQUIRED for this vacancy:Resume "Required" indicates that the above documents are required to determine your qualification for this vacancy. These documents are collected from ALL applicants and failing to provide any of these documents may result in your application being deemed incomplete or not qualified. Pay close attention to the list above to ensure you are providing all of the documentation we need to consider your application.RESUME REQUIREMENTS: The Federal Government has very specific requirements for the information that you must include in your resume. A resume for a Federal job will be much longer and more complete than the type of resume you may be familiar with from the private sector. If you have not written a Federal resume before, you may want to watch this on the , or read through a helpful on the .The following documents are ACCEPTED for this vacancy:Cover LetterDD-214CTAP, ICTAP, Schedule A documentsVeteran Administration LetterResumeSF-15SF-50Transcript "Accepted" means that you will have the opportunity to submit these documents if they are applicable to you. Such documents include Veteran Preference or other special eligibility documentation, transcripts, or other optional documentation that helps us determine your eligibility. The above list of documents may not apply to all applicants.STATUS CANDIDATES - REQUIRED DOCUMENT DETAILSCurrent and former Federal employees: You will need to submit a copy of your most recent SF-50 (Standard Form 50 - Notice of Personnel Action). To properly verify status eligibility, your SF-50 must show the following. If you do not submit an appropriate SF-50, we cannot verify your status eligibility! Full position title;Appointment type;Occupational series;Pay plan, series, grade, and step;Tenure code; andService Computation Date (SCD). If your current position SF-50 does not indicate you have competitive service status or does not reflect the pay plan and grade of the highest position you have held in the competitive service, in addition to your current SF-50, you must provide your previous SF-50s that provide the proof of competitive status and highest grade held on a permanent basis.Veterans: You will need to submit appropriate (DD-214 Member #4 Copy, VA Letter, Standard Form (SF) 15 as applicable). Please note: If you are a veteran who has not yet been discharged, you may provide a statement of intent to discharge from your agency to receive Veterans Preference under the VOW (Veterans Opportunity to Work) to Hire Heroes Act of 2011.Persons with Disabilities: Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities may apply for appointment through the Schedule A hiring authority. from a licensed medical professional; a licensed vocational rehabilitation specialist; or any Federal, state, or District of Columbia agency or U.S. territory that issues or provides disability benefits will be required.Displaced Federal employees who qualify for CTAP/ICTAP: If you are a former Federal employee who was displaced due to a Reduction-in-Force (RIF) or surplused by some other means, please submit a copy of the separation letter or RIF notice from your agency. To be selected under I/CTAP, you must still be found well-qualified for this position. Please see the OPM for more information. If you are relying on your education to meet qualification requirements: Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from . Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating. Benefits Benefits A career with the U.S. Government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. . Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time, or intermittent. Contact the hiring agency for more information on the specific benefits offered. How to Apply How to ApplyTo apply for positions with the Food & Drug Administration, you must have a USAJOBS account and be signed in to that account when you click "Apply Online". Additionally, you must provide a resume, any required supporting documentation listed on the announcement, and you must complete all assessment questionnaires BEFORE 11:59 pm Eastern Time on the closing date of this announcement, 05/09/2018 We recommend that you start the application process early enough that you can complete and submit your application before this deadline. Please note that you cannot submit documentation or make changes to your application after the deadline, and in most cases, only experience and education obtained by this date will be considered. If you would like to learn how to use USAJOBS including: accessing and managing your account, adding saved documents, building a resume, or starting an application; we recommend you visit the USAJOBS How To site, and read up on any topic that you need help with. This site is located at: . Additionally, if you need technical assistance with USAJOBS (such as account issues) please visit the main USAJOBS Help site at: .The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are unfamiliar with Application Manager, and you encounter any difficulty with the site, we recommend that you first consult the Applicant Help Site at: . This help site contains step-by-step instructions for completing the application process, submitting documentation, and completing questionnaires, and should be very helpful to you! You are encouraged to apply online. Applying online will allow you to review and track the status of your application. The FDA will provide reasonable accommodation to applicants with disabilities who are not able to apply online. If you need a reasonable accommodation for any part of the application process, please contact the Applicant Help Desk. Decisions on granting a reasonable accommodation will be made on a case-by-case basis. If after reviewing the and help sites, you're not able to find the answer to your question or concern, or if you wish to request a reasonable accommodation, please contact the FDA Applicant Help Desk at 888-478-4340, or e-mail . The Applicant Help Desk is staffed between the hours of 7am and 6pm Eastern Time, Monday through Friday, except for government holidays. If you contact the Applicant Help Desk, please provide the following Vacancy Identification Number (VIN) 10194543 so that we may assist you faster.Agency contact informationFDA Applicant Help Desk FDA Applicant Help Desk PhoneEmailAddress Center for Veterinary Medicine 10903 New Hampshire Ave Silver Spring, MD US Next steps Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview. We strive to make selections within 45 days of the closing date of this announcement.You will application status updates via email and via USAJOBS as the process unfolds. Fair & Transparent Fair & Transparent The Federal hiring process is setup to be fair and transparent. Please read the following guidance. Equal Employment Opportunity Policy The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor. Reasonable Accommodation Policy Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application and hiring process should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis. A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits. Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when: An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job.An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace.An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events. You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis. Learn more about or Legal and regulatory guidance
Quality Assurance Specialist
Duties DutiesSummaryJoin the Center for Veterinary Medicine (CVM) in the protection of human and animal health. At CVM, we are responsible for regulating food, food additives, drugs, and devices for millions of pets and food-producing animals. As a high performance organization, we strive for leadership, innovation, and excellence across all operations, occupations, and grade levels. about why CVM is the best fit for your talents. Begin your career with CVM today.Who May Apply: Federal employees with career or career-conditional appointments in the competitive service; former Federal employees with reinstatement eligibility based on previous career or career-conditional appointments; displaced Federal employees requesting special priority selection consideration under the Career Transition Assistance Plan (CTAP) and the Interagency Career Transition Assistance Plan (ICTAP); veterans eligible under provisions of VEOA who are preference eligibles or who have been separated under honorable conditions after 3 years or more of continuous active service; Military Spouses; PHS Commissioned Corps Officers; individuals eligible for VRA appointments (at the GS-11 and below grade levels); and individuals with disabilities. . This vacancy is also being announced concurrently with vacancy announcement FDA-CVM-18-DE-10193889 under delegated examining procedures. Please review that announcement to see if you are eligible for consideration under delegated examining procedures. Applicants must apply separately for each announcement in order to be considered under both.Additional selections may be made within the same geographical area FDA-wide.ResponsibilitiesThis position is located in the FDA, Office of Foods and Veterinary Medicine, Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE), Division of Business Information Science and Management in Rockville, Maryland.ONADE's primary responsibility is to review information submitted by drug sponsors who want approval to market animal drugs.ONADE accomplishes its mission by ensuring four critical review standards are met before a drug is approved for marketing.First, animal drugs must be safe; safe for the animal, safe for the humans consuming food derived from treated animals and safe for the user or the person administering the drug.Second, animal drugs must be effective for their intended uses.Third, animal drugs must be quality manufactured in accordance with current Good Manufacturing Practice regulations.Fourth, animal drugs must be properly labeled to accurately inform the end-user on how to use the drug safely and effectively.In addition, ONADE considers the impact of an animal drug on the environment during the review process.As a Quality Assurance Specialist in ONADE, you will:Develop plans and projects for achieving and maintaining quality assurance under Good Laboratory Practice Regulations and Good Clinical Practice Guidance.You will conduct quality assurance study reviews of new animal drug applications and drug approval packages to ensure quality and compliance with CVM/FDA regulatory requirements.You will also provide advice and guidance on Good Laboratory Practice Regulations, Good Clinical Practice Guidance, Standard Operating Procedures, Food, Drug and Cosmetic Act, and Title 21 of the Federal Regulations.Travel RequiredNot required Supervisory status No Promotion Potential 13 Job family (Series) Requirements Requirements Conditions of EmploymentCitizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement.Time-in-Grade Requirement: If you are applying as a current Federal employee, you must meet the time-in-grade requirements described in the Qualifications section, generally, 52-weeks of comparable experience at the next lowest grade.Selective Service Registration: All males born on, or after, 12/31/1959, must be registered with the Selective Service OR have an approved exemption.FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the problem.Security and Background Requirements: Appointment will require passing a background investigation. Not meeting this requirement may be grounds for personnel action. If hired, you may be subject to a background check at a later time.Certification of Accuracy: All information concerning qualification for employment is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection or appropriate disciplinary action.Direct Deposit: You will be required to have your federal salary payments electronically deposited into an account with a financial institution of your choice.You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and qualifications attained by this date will be considered. QualificationsIn order to qualify for Quality Assurance Specialist, 1910, at GS - 12, you must meet Time-in-Grade requirements by 05/09/2018. Selective Placement Factor: You must possess one year of regulatory quality assurance experience conducting quality assurance reviews of clinical and/or nonclinical laboratory studies in support of drug approvals to determine compliance with regulatory requirements.ANDBasic Requirements You must possess a degree with a major study of quality assurance, statistics, mathematics, production management, industrial management, computer science, engineering, engineering technology, physical sciences, textiles, or other fields related to the position.OR Possess one year experience that demonstrates a practical knowledge in monitoring, controlling or maintaining the quality of products or services in quality assurance, procurement, inspection, production or related areas. Examples includes: Experience reviewing production activities and capabilities in light of contract quality requirements.Reviewing written quality or inspection procedures for adequacy, and evaluating the implementation and effectiveness of quality/inspection systems, including sampling plans;Analyzing quality data to detect unsatisfactory trends or weaknesses in the quality/inspection system.Verifying by test or inspection, using sampling inspection or intensive product inspection techniques that products comply with requirements prior to acceptance.Identifying inadequacies and requesting corrective action;Computing data, summarizing results, and preparing reports or charts depicting pertinent relationships using statistical methods.Investigating customer complaints and deficiency reports, and providing identification of causes to appropriate authorities.Reading, interpreting, and applying technical data such as blueprints, engineering drawings, product specifications, or technical manuals;Reviewing and evaluating supply systems operations and procedures through periodic audits and surveillance inspection.ANDMinimum Qualifications for GS-12 You must possess one year of specialized experience equivalent to at least the GS-11 level in the Federal service. Experience includes:developing, implementing, and/or executing programs, plans, or projects to achieve and maintain quality assurance under Good Laboratory Practice Regulations and/or Good Laboratory Practice Guidance; performing quality assurance reviews/assessments of drug study reports to ensure compliance with Good Laboratory Practice Regulations and/or Good Laboratory Practice Guidance; and providing guidance on laws, regulations, and guidelines governing quality assurance programs/plans in a regulatory environment. This experience must be reflected in your resume. Volunteer experience can also be used as qualifying experience. In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above.PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.You must submit documentation to verify your eligibility to apply for this vacancy. For most applicants, an SF-50 will be required. However, if you are applying based as a Veteran, person with a disability, or a displaced former employee, you will be required to provide other supporting documents as applicable. See the Required Documents section for more details.EducationForeign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For more information about this requirement, please visit the .Additional informationADDITIONAL CONDITIONS OF EMPLOYMENT:Pre-employment physical required: NoDrug testing required: NoLicense required: NoMobility agreement required: NoImmunization required: NoBargaining Unit Position: YesIncentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.If you are serving, or have served in the last 5 years (from 05/09/2018) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. Veteran's Preference: If you plan to apply for any kind of Veteran Preference, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. .Schedule A: If you plan to apply under Schedule A based on a disability, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. Inter-agency and Career Transition Assistance Programs: If you are a displaced Federal employee and plan to apply under CTAP or ICTAP, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. Financial disclosure statement, OGE-450, required: NoAs part of a Government-wide initiative to increase the efficiencies in the use of Federal real estate by creating new alternative office solutions, ONADE operates in a hoteling work environment. Hoteling is an arrangement where employees reserve non-dedicated, non-permanent workspace at the duty station on an as needed basis and as required (when in person attendance is deemed important and regardless of need, no less than 2 days per pay period). ONADE provides the basic technology needed to effectively work in the Rockville office and in a teleworking location (e.g., laptop, monitors, webcam). Hoteling, along with a strong telework program and strong electronic communication and workflow tools, affords employees in ONADE the flexibility to balance work/life demands while contributing to our high performing organization.All requirements must be met by the closing date of this announcement (05/09/2018); only education and experience gained by this date will be considered. How You Will Be EvaluatedYou will be evaluated for this job based on how well you meet the qualifications above. Once the job opportunity announcement closes (at 11:59 pm ET on 05/09/2018), a review of your resume and supporting documentation will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your eligibility for Federal employment, and then whether or not you are qualified for this particular position. If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible or your score may be adjusted to more accurately reflect your skills and abilities.Please follow all instructions carefully. Errors or omissions may affect your eligibility.Interview Process: Structured interviews; may be asked scenario-based interview questions concerning core competencies. Method/tools used to evaluate applicants: work samples, conducting a presentation, reference checks, tests may be used.Basis of Rating: Merit Promotion Procedures for the Food and Drug Administration (FDA) will be used to rate and rank candidates. The category assignment is a measure of the degree in which your background matches the competencies required for this position. Qualified candidates will be ranked into one of two categories: Best Qualified or Qualified.Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You need not respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of these Competencies.Quality Assurance Program ManagementRegulatory Compliance ManagementTechnical AdvisorTo review the application questionnaire, click the link below.Background checks and security clearanceSecurity clearance Required Documents Required DocumentsThe following documents are REQUIRED for this vacancy:Resume "Required" indicates that the above documents are required to determine your qualification for this vacancy. These documents are collected from ALL applicants and failing to provide any of these documents may result in your application being deemed incomplete or not qualified. Pay close attention to the list above to ensure you are providing all of the documentation we need to consider your application.RESUME REQUIREMENTS: The Federal Government has very specific requirements for the information that you must include in your resume. A resume for a Federal job will be much longer and more complete than the type of resume you may be familiar with from the private sector. If you have not written a Federal resume before, you may want to watch this on the , or read through a helpful on the .The following documents are ACCEPTED for this vacancy:Cover LetterDD-214CTAP, ICTAP, Schedule A documentsVeteran Administration LetterResumeSF-15SF-50Transcript "Accepted" means that you will have the opportunity to submit these documents if they are applicable to you. Such documents include Veteran Preference or other special eligibility documentation, transcripts, or other optional documentation that helps us determine your eligibility. The above list of documents may not apply to all applicants.STATUS CANDIDATES - REQUIRED DOCUMENT DETAILSCurrent and former Federal employees: You will need to submit a copy of your most recent SF-50 (Standard Form 50 - Notice of Personnel Action). To properly verify status eligibility, your SF-50 must show the following. If you do not submit an appropriate SF-50, we cannot verify your status eligibility! Full position title;Appointment type;Occupational series;Pay plan, series, grade, and step;Tenure code; andService Computation Date (SCD). If your current position SF-50 does not indicate you have competitive service status or does not reflect the pay plan and grade of the highest position you have held in the competitive service, in addition to your current SF-50, you must provide your previous SF-50s that provide the proof of competitive status and highest grade held on a permanent basis.Veterans: You will need to submit appropriate (DD-214 Member #4 Copy, VA Letter, Standard Form (SF) 15 as applicable). Please note: If you are a veteran who has not yet been discharged, you may provide a statement of intent to discharge from your agency to receive Veterans Preference under the VOW (Veterans Opportunity to Work) to Hire Heroes Act of 2011.Persons with Disabilities: Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities may apply for appointment through the Schedule A hiring authority. from a licensed medical professional; a licensed vocational rehabilitation specialist; or any Federal, state, or District of Columbia agency or U.S. territory that issues or provides disability benefits will be required.Displaced Federal employees who qualify for CTAP/ICTAP: If you are a former Federal employee who was displaced due to a Reduction-in-Force (RIF) or surplused by some other means, please submit a copy of the separation letter or RIF notice from your agency. To be selected under I/CTAP, you must still be found well-qualified for this position. Please see the OPM for more information. If you are relying on your education to meet qualification requirements: Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from . Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating. Benefits Benefits A career with the U.S. Government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. . Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time, or intermittent. Contact the hiring agency for more information on the specific benefits offered. How to Apply How to ApplyTo apply for positions with the Food & Drug Administration, you must have a USAJOBS account and be signed in to that account when you click "Apply Online". Additionally, you must provide a resume, any required supporting documentation listed on the announcement, and you must complete all assessment questionnaires BEFORE 11:59 pm Eastern Time on the closing date of this announcement, 05/09/2018 We recommend that you start the application process early enough that you can complete and submit your application before this deadline. Please note that you cannot submit documentation or make changes to your application after the deadline, and in most cases, only experience and education obtained by this date will be considered. If you would like to learn how to use USAJOBS including: accessing and managing your account, adding saved documents, building a resume, or starting an application; we recommend you visit the USAJOBS How To site, and read up on any topic that you need help with. This site is located at: . Additionally, if you need technical assistance with USAJOBS (such as account issues) please visit the main USAJOBS Help site at: .The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are unfamiliar with Application Manager, and you encounter any difficulty with the site, we recommend that you first consult the Applicant Help Site at: . This help site contains step-by-step instructions for completing the application process, submitting documentation, and completing questionnaires, and should be very helpful to you! You are encouraged to apply online. Applying online will allow you to review and track the status of your application. The FDA will provide reasonable accommodation to applicants with disabilities who are not able to apply online. If you need a reasonable accommodation for any part of the application process, please contact the Applicant Help Desk. Decisions on granting a reasonable accommodation will be made on a case-by-case basis. If after reviewing the and help sites, you're not able to find the answer to your question or concern, or if you wish to request a reasonable accommodation, please contact the FDA Applicant Help Desk at 888-478-4340, or e-mail . The Applicant Help Desk is staffed between the hours of 7am and 6pm Eastern Time, Monday through Friday, except for government holidays. If you contact the Applicant Help Desk, please provide the following Vacancy Identification Number (VIN) 10194543 so that we may assist you faster.Agency contact informationFDA Applicant Help Desk FDA Applicant Help Desk PhoneEmailAddress Center for Veterinary Medicine 10903 New Hampshire Ave Silver Spring, MD US Next steps Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview. We strive to make selections within 45 days of the closing date of this announcement.You will application status updates via email and via USAJOBS as the process unfolds. Fair & Transparent Fair & Transparent The Federal hiring process is setup to be fair and transparent. Please read the following guidance. Equal Employment Opportunity Policy The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor. Reasonable Accommodation Policy Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application and hiring process should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis. A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits. Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when: An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job.An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace.An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events. You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis. Learn more about or Legal and regulatory guidance
See More