| Key Responsibilities
Internal Audits & Compliance
- Plan, schedule, and conduct internal cGMP audits of laboratory, manufacturing, warehousing, sanitation, documentation, and quality systems.
- Audit compliance with FDA 21 CFR Part 111 (Dietary Supplements), Part 117 (FSMA), SOPs, and internal quality standards.
- Evaluate laboratory practices including testing methods, equipment calibration, data integrity, and documentation.
- Prepare clear, accurate audit reports detailing observations, risks, and recommendations.
- Track audit findings and verify completion and effectiveness of CAPAs.
Quality Systems
- Support and monitor the effectiveness of the Quality Management System (QMS).
- Review and audit SOPs, batch records, test methods, specifications, and logbooks.
- Ensure document control, change control, deviation, and CAPA systems are properly implemented.
- Participate in management review meetings and quality metrics reporting.
Regulatory Readiness
- Support FDA, state, and third-party inspections (NSF, USP, SQF, ISO, etc.).
- Perform mock audits and pre-inspection readiness assessments.
- Assist in responding to regulatory observations (e.g., FDA 483s, warning letters).
Training & Continuous Improvement
- Provide cGMP and audit-related training to laboratory and production staff.
- Identify trends, recurring issues, and opportunities for continuous improvement.
- Promote a culture of compliance, quality, and data integrity.
Qualifications
Education
- Bachelor’s degree in Life Sciences, Chemistry, Biology, Food Science, or a related field required.
Experience
- 3–5 years of Quality Assurance experience in a nutraceutical, pharmaceutical, food, or regulated laboratory environment.
- Hands-on experience conducting internal cGMP audits.
- Strong working knowledge of FDA dietary supplement regulations.
Knowledge & Skills
- In-depth understanding of:
- o FDA cGMPs (21 CFR Part 111 & 117)
- o Internal audit principles
- o CAPA and root cause analysis
- o Laboratory quality systems and data integrity
- Excellent documentation, writing, and analytical skills.
- Strong attention to detail and ability to work independently.
- Proficiency with QMS software and Microsoft Office.
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