Location:
New Jersy (On-site)
Duration:
6 Months
Start Date:
Immediate
Industry:
Biologics / CDMO
Type:
Contract
Key Responsibilities
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Review GMP data (HPLC, UPLC, CE-SDS, icIEF, ELISA, qPCR) and ensure GDP-compliant documentation
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Perform or oversee release, stability, and in-process testing
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Support method qualification, validation, and SOP documentation
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Lead or assist with OOS/OOT investigations and CAPA follow-up
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Collaborate with QA, manufacturing, and analytical teams; support audits and technical reviews
Ideal Candidate
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5–10 years of QC experience in GMP settings (biologics/conjugates preferred)
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Strong in data review, validation, and technical writing
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Independent, detail-oriented, and audit-ready
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Familiar with CDMO environments and systems like LIMS, Veeva, or Trackwise
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Available for immediate start