Quality Assurance Supervisor-Dietary Supplement Manufacturing

Position Summary:

The Quality Assurance (QA) Supervisor ensures that all products manufactured in the facility comply with FDA regulations, including 21 CFR Part 111 (Dietary Supplement cGMP), internal SOPs, and quality standards. This role involves monitoring production, documentation, and testing processes to ensure product safety, identity, purity, strength, and composition.

Key Responsibilities:

• Ensure compliance with FDA dietary supplement cGMP regulations (21 CFR Part 111)
• Inspect, sample, test, and approve incoming raw materials
• Verify COAs and ensure conformance to specifications
• Perform line clearance, in-process checks, and final product inspections
• Investigate and document non-conformances, deviations, OOS results, and CAPAs
• Conduct in-process quality checks and monitor operations for compliance
• Monitor and audit cleanroom practices, sanitation logs, and environmental controls
• Assist in internal audits, regulatory inspections, and third-party certifications
• Review and maintain SOPs, change control documents, and quality logs
• Maintain and calibrate QC instruments
• Coordinate stability studies, raw material qualification, and vendor qualification
• Train staff on GMP, SOPs, and quality procedures

Qualifications:

• Bachelor’s degree in Life Sciences, Chemistry, Microbiology, or related field
• 1–3 years of QA or QC experience in dietary supplements, pharmaceuticals, or food manufacturing
• Strong knowledge of FDA cGMP (21 CFR Part 111)
• Excellent attention to detail and documentation skills
• Ability to interpret COAs, testing data, and regulatory standards
• Proficiency in MS Office

Preferred:

• Experience with third-party audits (e.g., NSF, UL, ISO, FDA inspections)
• Certification in HACCP, PCQI, or GMP Training (not required, but a plus)
• Bilingual: Spanish

Physical Requirements:

• Lift up to 25 lbs when needed

Reports To:

Quality Control Manager