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Quality Control Senior Associate
Job Description
Responsibilities:
- Execute QC second shift activities, working with the day and night shift team leads, including sample receipt, prioritization, and accurate entry into LIMS.
- Serve as a point of contact for Manufacturing during night shift operations, supporting production schedules, issue resolution, and risk escalation.
- Independently perform routine and complex analytical testing in chemistry, bioassay, and/or microbiology, including STAT testing as required.
- Ensure accurate, compliant documentation in accordance with GDP, GMP, and 21 CFR Part 11 requirements.
- Support laboratory investigations related to deviations or OOS results and communicate shift-level risks to QC leadership.
- Utilize electronic systems including LIMS, Biovia (LES, ELN, CIMS/CISPro), and Veeva Vault (QualityDocs, QMS).
- Collaborate cross-functionally to meet testing timelines and contribute to continuous improvement initiatives.
- Experience working in a GMP-regulated Quality Control laboratory with demonstrated ability to work independently.
- High school/GED + 2 years work experience OR? Associates and 6 months work experience OR? Bachelors
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