Senior Quality Compliance Specialist

The Senior Quality Compliance Specialist oversees internal audit execution and coordination across four manufacturing and/or packaging sites within a dietary supplement organization. This role serves as the primary coordinator for external audits, customer audits, and third-party certification audits, ensuring audit readiness, effective communication, and timely response management in accordance with 21 CFR Part 111 and applicable food safety standards.

What You Will Do

Develop, implement, and maintain the internal audit program across four sites using a risk-based approach. Conduct audits and/or lead audit teams, document audit findings objectively, and track findings to closure. Prepare, review, and submit audit responses and inspection findings in alignment with CAPA requirements.

Why It Might Be a Fit

The ideal candidate will have 3–5 years of experience in Quality Assurance within dietary supplement or pharmaceutical manufacturing, demonstrated experience conducting or coordinating internal and external audits, and a strong working knowledge of FDA 21 CFR Part 111 (Dietary Supplement cGMPs).

Requirements

• Bachelor’s degree in Quality, Food Science, Biology, Chemistry, or a related discipline
• 3–5 years of experience in Quality Assurance within dietary supplement or pharmaceutical manufacturing
• Demonstrated experience conducting or coordinating internal and external audits
• Strong working knowledge of FDA 21 CFR Part 111 (Dietary Supplement cGMPs)
• Experience managing audit responses, CAPAs, and audit documentation
• Certified Internal Auditor, ASQ CQA, PCQI, or similar quality/audit-related certification
• Experience supporting FDA inspections or major customer audits
• Familiarity with electronic QMS platforms (e.g., audit tracking, CAPA systems)
• Experience working in a multi-site or multi-location manufacturing environment
• Attention to detail and strong documentation skills
• Ability to work independently and across cross-functional teams
• Professional judgment and discretion during audits
• Strong time management and prioritization skills
• Continuous improvement mindset

Benefits

• Competitive salary
• Opportunity to work in a multi-site or multi-location manufacturing environment
• Experience working with electronic QMS platforms
• Support for professional certifications and training
• Opportunity to work in a dynamic and inclusive work environment