Quality Assurance Supervisor

Role & Responsibility

• Supervise and develop QA Inspectors, Label Issuance staff, and Team Leads; provide coaching, performance accountability, conflict resolution, and consistent policy enforcement.
• Oversee QA inspection activities, production-process monitoring, and label cage operations and personnel.
• Review and approve protocols; review SOPs, processes, batch records, and procedures, and update documentation to improve consistency and compliance.
• Partner with Production Supervisors to resolve manufacturing and quality issues, and collaborate with Production, New Product Development, and other departments on quality-system activities.
• Monitor environmental-condition records, respond to excursions, and review pest-control, calibration, and related quality records.
• Investigate deviations and nonconformances; assess potential effects on product quality, safety, and purity; prepare and close NCRs and document corrective actions.
• Ensure compliance with applicable cGMP requirements, FDA regulations, industry standards, and company policies; support product quality and regulatory readiness.
• Develop and implement processes that strengthen compliance, operational consistency, and continuous improvement, including Lean manufacturing practices where applicable.
• Enforce safe work practices, identify and correct unsafe conditions, train employees on hazard recognition, and follow up on corrective measures.
• Coordinate incident response and reporting with EHS and appropriate response teams; support incident investigations, including 5-Why root-cause analysis and corrective actions.
• Communicate effectively across shifts and departments; periodically adjust shift hours to support personnel on other shifts.
• Perform additional duties as assigned.

Skills & Experience

• High school diploma required; an Associate or Bachelor’s degree, preferably in a science-related field, is preferred.
• 4–5 years of experience in an FDA-regulated manufacturing or production environment, including at least 3 years in Quality Assurance or Quality Control.
• Experience in nutritional supplements and/or pharmaceutical manufacturing.
• Strong working knowledge of cGMP, SOPs, batch records, deviations, nonconformances, and quality documentation.
• Experience with ISO standards, dietary supplements, and Lean manufacturing practices is desirable.
• Prior FDA or equivalent regulatory inspection experience is highly preferred.
• Demonstrated supervisory leadership, including difficult employee conversations, performance accountability, conflict resolution, and policy compliance.
• Strong cross-functional communication skills and a commitment to continuous improvement.
• Ability to work the stated second-shift schedule, train initially on first shift, and periodically support other shifts.