Quality Control Senior Associate

Note:Fully Onsite - Holly Springs NCWork Schedule: 2nd shift 2PM - 10PM Sunday - Wednesday or Wednesday - SaturdayFirst few weeks of training will be on DayshiftThe 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.