Quality Systems Compliance Specialist (cGMP)

Quality Systems Compliance Specialist (cGMP)

Picture your day in a fast-moving, around-the-clock operation. At 8 : 30 a.m., you review overnight quality metrics to spot trends. By late morning, you’re walking the floor with auditors, ensuring our Quality Management System (QMS) stands tall under scrutiny. Afternoon brings a root-cause investigation, a CAPA plan, and a quick SOP revision routed through change control. You finish by logging training completions and helping QA release batch records—another day safeguarding compliance and patient safety.

This role reports to the Senior Manager of Regulatory Compliance and supports the maintenance and continuous improvement of site-wide regulatory compliance in a 24 / 7, high-speed environment.

What you’ll do

• Co-pilot regulatory compliance for the site, partnering closely with QA to identify gaps and drive effective closures.
• Execute and host audits (internal, client, and regulatory); help schedule and run the internal audit program and verify timely, effective CAPA completion.
• Manage critical QMS elements : investigations and CAPAs, policies and procedures, change controls, document management, customer complaint handling, and training performance / recordkeeping.
• Ensure our QMS aligns with client and company expectations and complies with 21 CFR Parts 111, 210, 211, and 820.
• Support the site during regulatory and client inspections / audits with strong documentation and on-the-spot coordination.
• Analyze quality metrics to identify trends and areas of immediate concern; escalate to leadership when needed.
• Contribute to continuous improvement initiatives and adapt quickly to shifting priorities and workloads.
• Assist with Document Control and support Batch Record creation, review, and release, as required.
• Provide general support across all Quality Assurance functions.

What you’ll bring

Equal Opportunity

Nutra-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.

Ready to grow?

If you’re energized by audits, love turning data into action, and want to help a 24 / 7 operation operate compliantly and efficiently, we’d love to hear from you. Apply today.