QC Manager
Elite Recruit LLC
Overview Industry: Nutraceuticals / Dietary Supplements (CDMO) Location: New Brunswick, NJ Job Summary The Quality Control (QC) Manager is responsible for overseeing all laboratory and quality control functions within a dietary supplement CDMO environment. This role ensures that raw materials, in-process samples, and finished products meet established specifications and comply with regulatory requirements including FDA 21 CFR Part 111 and cGMP standards. The QC Manager will lead laboratory operations, manage a team of analysts, and support timely product release while maintaining the highest standards of quality, safety, and data integrity. Responsibilities Oversee testing of raw materials, in-process samples, and finished products. Ensure compliance with product specifications and release criteria. Review and approve Certificates of Analysis (COAs). Manage sampling plans, test schedules, and batch release timelines. Supervise day-to-day QC laboratory operations (chemical and microbiological testing). Ensure proper calibration, maintenance, and operation of analytical instruments (HPLC, GC, UV-Vis; ICP-MS is a plus). Maintain laboratory SOPs, test methods, and documentation. Support internal, customer, and regulatory audits. Maintain audit readiness and address observations. Lead investigations for OOS (Out-of-Specification) and OOT (Out-of-Trend) results. Lead, train, and mentor QC analysts and lab personnel. Manage team performance, hiring, and development. Promote a strong quality and compliance culture. Partner with QA, Manufacturing, R&D, and Supply Chain teams. Support product development, scale-up, and tech transfer activities. Drive improvements in lab efficiency, turnaround time, and cost optimization. Qualifications Bachelor’s or Master’s degree in Chemistry, Biochemistry, Microbiology, Food Science, or related field. 5+ years of experience in Quality Control within dietary supplements and nutraceuticals. Experience in a CDMO or contract manufacturing environment preferred. Hands-on experience with analytical techniques such as HPLC, GC, UV-Vis (ICP-MS is a plus). Strong knowledge of microbiological testing methods. Experience with method validation and stability studies. Ability to work in a fast-paced, multi-client CDMO environment. Effective communication and stakeholder management. #J-18808-Ljbffr Elite Recruit LLC
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