Sr. Quality Compliance Specialist

About the Role

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. The position supports the Quality Management System (QMS) through technical writing, deviation and nonconformance investigations, CAPA administration, and continuous improvement initiatives, maintaining regulatory compliance and strengthening audit performance.

Responsibilities

• Develop, implement, and maintain the internal audit program across four sites using a risk-based approach.
• Create and manage the annual audit schedule; conduct audits and/or lead audit teams.
• Document audit findings objectively, issue reports within defined timelines, and track findings to closure.
• Serve as a primary QA point of contact for external audits, including audit planning, logistics, and on-site/backroom coordination.
• Manage audit-day documentation requests and coordinate accurate, timely responses.
• Prepare, review, and submit audit responses and inspection findings in alignment with CAPA requirements.
• Progressively assume front-facing responsibilities during external audits.
• Initiate, author, and manage deviations, nonconformances, and CAPAs, including root cause analysis, corrective/preventive actions, and effectiveness checks.
• Trend audit findings, deviations, and CAPAs to identify systemic issues and improvement opportunities.
• Generate audit and compliance metrics and present summaries to QA leadership.
• Maintain audit records and ensure compliance with document retention requirements.
• Draft, revise, and maintain SOPs, work instructions, forms, and quality records to ensure regulatory compliance and clarity.
• Support document control activities, including review cycles, approvals, version control, and periodic review.
• Update documentation and training materials based on audit outcomes and regulatory expectations.
• Support Quality-on-the-Floor initiatives and collaborate with Operations, Engineering, and other cross-functional teams.
• Work on a personal computer in a stationary position for extended periods.
• Act professionally in an office and manufacturing environment.
• Comply with company confidentiality and security standards and guidelines.
• Maintain good attendance and flexibility to assist with workloads due to absences or varying hours.
• Perform physical tasks such as walking, standing for extended periods, and lifting totes/bins/boxes (up to 20 lbs.).
• Work in a moderate noise-level environment.
• Perform individual tasks and assignments to support department efficiency.
• Other duties as assigned by the department manager.

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); familiarity with food safety standards (e.g., HACCP, FSMA) is a plus.
• Experience managing audit responses, CAPAs, and audit documentation.
• Excellent organizational skills with the ability to manage multiple audits across multiple sites simultaneously.
• Strong written and verbal communication skills, including professional interaction with auditors and regulators.

Skills

• Certified Internal Auditor, ASQ CQA, PCQI, or similar quality/audit-related certification (preferred).
• 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.