Sr. Quality Compliance Specialist

Position Overview 

The Senior Quality Compliance Specialist is responsible for overseeing 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. 

In addition, this role supports the Quality Management System (QMS) through technical writing, deviation and nonconformance investigations, CAPA administration, and continuous improvement initiatives. The position plays a critical role in maintaining regulatory compliance, strengthening audit performance, and ensuring consistency and effectiveness of quality systems across multiple sites.

Specific Responsibilities  

Audit Management & Coordination 

• 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. 

CAPA, Documentation & Continuous Improvement 

• 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. 

Technical Writing & Compliance Support 

• 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. 

General Responsibilities 

• Ability to work on a personal computer in a stationary position for extended periods of time during the day. 

• Act professionally in an office environment. 

• Comply with company confidentiality and security standards and guidelines. 

• Good attendance is required. Must be flexible to assist with workloads due to absences and work flexible hours when requested. 

• Walking and standing for an extended period.  

• Lift Totes / Bins / Boxes with manufacturing documents or retain (~20 lbs.). 

• Work in a moderate noise level environment.  

• Perform individual tasks and assignments to help with the department's efficiency.    

• Other duties as assigned by department manager. 

The Candidate 

Education, Experience, and Licenses: 

• 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. 

Knowledge, Skills, and Abilities 

• 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 

International Vitamin Corporation (IVC) Is an Equal Opportunity Employer. Our organization remains steadfast in our commitment to fostering an inclusive and non-discriminatory work environment that welcomes individuals from all backgrounds. We firmly maintain the belief that every individual ought to be treated with respect and dignity, regardless of their race, color, religion, sex, sexual orientation, gender identity or expression, age, national origin, disability, veteran status, marital status, genetic information, or any other protected characteristic, as defined by the law. We pledge that all eligible job applicants shall receive an impartial and unbiased evaluation during the recruitment process, without any form of discrimination based on any of the protected class. Our dedication to promoting diversity and inclusivity remains unwavering, and we take immense pride in cultivating a workplace culture that values and celebrates differences. Our efforts towards creating an environment that is free from prejudice and discrimination are an integral part of our organizational philosophy, and we stand committed to upholding these principles.