Sr. Quality Compliance Specialist

Overview

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, andtimelyresponse 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 inmaintainingregulatory compliance, strengthening audit performance, and ensuring consistency and effectiveness of quality systems across multiple sites.

Specific Responsibilities

Audit Management & Coordination

• Develop, implement, andmaintainthe 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, andsubmitaudit 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 toidentifysystemic 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, andmaintainSOPs, 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 toassistwith workloads due to absences and work flexible hours when requested.

• Walking and standing for an extended period.

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

• 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, ora 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 SupplementcGMPs); 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…