Quality Assurance Manager

Responsibilities

• Create, revise, and archive, controlled documents (MMRs, BPRs, SOPs, specs, forms) per 21 CFR Part 111
• Maintain raw material, in-process, and finished product specifications aligned with CoAs and label claims
• Manage document change control, approvals, and version tracking
• Maintain document control logs and master index for traceability
• Support audits and FDA inspections by organizing and retrieving records
• Ensure proper issuance, review, and filing of production records
• Assist with CAPA, deviations, and change control documentation
• Train staff on document control and GDP

Qualifications

• 3+ years document control experience in supplements, food, or pharma (supplements preferred)
• Strong knowledge of FDA 21 CFR Part 111 (MMRs, BPRs, recordkeeping)
• Experience with specification sheets and GDP/data integrity
• Detail-oriented with strong organizational and communication skills
• Proficient in Microsoft Office; QMS experience a plus
• Familiarity with CAPA and change control systems
• Experience in small-to-mid-size manufacturing environments

Pay

$90,000 - $110,000