Quality Control Senior Associate
Fully Onsite - Holly Springs NC
Work Schedule: 2nd shift 2PM - 10PM Sunday - Wednesday or Wednesday - Saturday
First few weeks of training will be on Dayshift
The ideal candidate will have at least 3 years of experience working in a GMP-regulated lab or manufacturing setting, with a strong background in writing and owning quality records such as deviations and CAPAs. Experience using the Veeva Quality system is highly desirable. This individual must demonstrate strong communication skills, a working understanding of QC laboratory processes. Candidates must be proactive, detail-oriented, and capable of contributing in a fast-paced environment with minimal oversight.
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.
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