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Sr. Microbiologist - USP, EP, JP, cGMP,FDA,21 CFR 210/211 at Apex Systems, Inc. in Summit, NJ

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Microbiologist - USP, cGMP, FDA, 21 CFR 210/211


The Sr. Microbiologist works both independently and with the team to perform routine and non-routine microbiological testing and microbiology laboratory maintenance functions, where necessary.


* Carry out responsibilities in accordance with the organizations policies, procedures, and state, federal and local laws.

* Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements at all times.

* Follow directions properly, work cooperatively as an individual contributor and as a team member.

* Assist in troubleshooting and solving problems that may come up in the day to day operation of the department.

* Participate in aseptic process qualifications, such as aseptic gowning and media fill reads.

* Perform Bacterial Endotoxin and Sterility Testing on in- process, stability and finished drug products.

* Perform microbial identification via polymerase chain reaction (PCR).

* Perform growth promotion testing of microbiological media.

* Perform mycoplasma testing via PCR.

* Perform microbial isolation techniques and perform Gram stain identifications.

* Send out samples to contract labs and track results/reports.

* Document laboratory test results on worksheets and forms utilizing Good Documentation Practices.

* Receives and stock test reagents, lab supplies and test media.

* Support continuous improvement projects related to QC

* Author and revise controlled documents such as Standard Operating Procedures and Controlled Forms. Author non routine Protocols/Validation Plans in support of projects.

* Assist with deviation, Investigations/CAPAs associated with Microbiological testing.

* Support data trending and tracking of results.

* Perform other duties as assigned.


* Requires Bachelors degree in Microbiology, Biotechnology, Molecular Biology, or related discipline

* Minimum 5 years of experience working in a regulated manufacturing environment.

* Microbiology lab experience strongly preferred. An equivalent combination of experience/education is acceptable.

* Have a good understanding of USP, EP, JP, and FDA microbiology testing requirements.

* Understanding of and ability to apply the regulations associated with 21 CFR 210/211.

* Good knowledge of Microsoft Word and Excel.

* Able to communicate effectively with GDPO functional areas and external agencies.

FOR IMMEDIATE CONSIDERATION please send your resume to grucci@apexlifesciences.com and add "Sr. Microbiologist" in the subject line of your application e-mail. Please call 732-636-1497 to discuss advancement role.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.

VEVRAA Federal Contractor
We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.
We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available here.

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