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QC Analyst at Apex Systems, Inc. in Lexington, MA

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Description

Primary responsibility include executing analytical testing to support methods being transfered and validated. Perform HPLC routine methods (Petide Map, Glycan Map, SEC, RP-Titer, Labchip and iCE) for transfer/validation and clinical testing in alignment with project timelines in a GMP maintained laboratory.

Summary:

  • Primary Duties of this position will focus on the daily lab operations and execution of
    testing to support manufacturing operations /validation/or development studies.
  • Testing may include but not limited to samples from drug substance and drug product
    manufacturing, stability, raw materials and various protocol studies using test methods
    derived from the various compendia and non-compendial sources.
  • May participate in more complex projects, operational excellence initiatives, and various quality systems with supervision.
  • Product Testing: Area focuses on techniques such as HPLC, SDS-PAGE, Capillary
    Electrophoresis, Potency and Bioassays.
  • Raw Materials: Area focuses on techniques such as wet chemistry compendial testing,
    Raman, NIR, titration assays, gas testing.
  • EM/Microbiology: Area focuses on techniques such as bioburden, endotoxin testing,
    growth promotion studies, environmental monitoring sampling and testing, microbial
    identifications.

  • 60% Testing execution
  • 30% QC operations support which entails data review, data trending,
    OE initiatives, maintenance of equipment and reagents, lab
    housekeeping, support for other QC groups (if necessary)
  • 10% Compliance and quality systems (SOP revisions, input to quality systems records)

Education and Experience Requirements

  • Normally requires a bachelor’s degree and a minimum of 0-2 year’s related experience (Science related degree is preferred)
  • Limited use and/or application of basic principles, theories, and concepts. Limited
    knowledge of industry practices and standards. Position requires critical thinking.
  • Key Skills: MS Office, LIMS, SAP, Trackwise, EDMS, compliance and strong science
    understanding

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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