QC Manager
Elite Recruit LLC
Job Title: Quality Control (QC) Manager
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, etc.)
- 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
Vacancy posted 4 days ago
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