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GxP Audit and CAPA Coordinator
2 weeks ago
Join a team that thrives on precision and improvement. In our high-velocity, 24/7 operation, you'll be the engine behind a robust Quality Management System—keeping procedures current, audits on track, risks mitigated, and training documented. You'll report directly to the Senior Manager of Regulatory Compliance and collaborate across QA to elevate our standards every day.
Your impact- Strengthen site regulatory compliance by spotting gaps and coordinating effective, timely CAPA implementation.
- Orchestrate QMS activities end-to-end: internal/client/regulatory audits, procedure and SOP updates, change control processing, document governance, complaint investigations, and training management/recordkeeping.
- Safeguard alignment with 21 CFR Parts 111, 210, 211, and 820, and with client and company requirements.
- Provide hands-on support during inspections and audits, ensuring records and responses reflect best practices.
- Turn data into decisions—enter, analyze, and trend quality metrics; escalate urgent issues to leadership.
- Contribute to continuous improvement and flex with shifting priorities in a fast-paced environment.
- Support Document Control; assist with Batch Record creation, review, and release; provide broad QA support as needed.
- Bachelor's degree or 2–5 years of QA experience in a regulated setting.
- Demonstrated experience performing quality system assessments for manufacturing/packaging locations and suppliers.
- Working knowledge of packaging systems and cGMP practices.
- Advanced computer literacy with spreadsheets, databases, and word processors; ERP experience is a plus.
- Clear, concise communicator who enjoys coaching others to meet Nutra-Med SOP expectations.
Expect exposure to audits, investigations, and change control that will sharpen your GxP toolkit and expand your influence across the organization.
Equal OpportunityNutra-Med Packaging, LLC., is an equal opportunity employer committed to fostering a diverse and inclusive workplace. We prohibit discrimination and harassment of any kind based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. We make hiring decisions based solely on qualifications, merit, and business needs at the time.
Take the next stepReady to drive audit readiness and CAPA excellence in a 24/7 operation? Apply now.
