Specialized Roles:
Sr. Quality Compliance Specialist
Job in
Anderson, Madison County, Indiana, 46016, USA
Listing for:
International Vitamin Corporation
Full Time
position
Listed on 2026-11-11
Job specializations:
-
Quality Assurance - QA/QC
QA Specialist - Analyst/Manager, Regulatory Compliance Specialist, Data Analyst
Job Description & How to Apply Below
Anderson:
Full time:
Posted 10 Days Ago:
JR - 2026 - 62
It's fun to work in a company where people truly BELIEVE in what they're doing! We're committed to bringing passion and customer focus to the business.
** 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…
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