QC Manager

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.

• 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.

• 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.