About this role
• Lead and support Quality Inspectors in daily inspection activities and quality-related decision making.
• Train and qualify inspectors on inspection methods, GMP requirements, documentation practices, and quality procedures.
• Monitor line components, part numbers, documentation, traceability, and compliance with approved specifications.
• Perform and verify in-process inspections including weights, code verification, label verification, functionality testing, appearance inspections, and other required quality checks.
• Verify components against Bills of Materials (BOMs), approved standards, and manufacturing documentation.
• Perform, review, and document required inspections, tests, and measurements.
• Assist Production and Quality Management in troubleshooting manufacturing and quality issues.
• Ensure nonconforming materials and products are properly identified, segregated, documented, and escalated for disposition.
• Support investigations related to customer complaints, deviations, nonconformances, and corrective actions.
• Coordinate customer sample submissions, approvals, and shipment activities.
• Generate, review, and upload quality documentation through customer portals, including COAs, COCs, customer questionnaires, product approval documentation, and investigation responses.
• Monitor customer portals and ensure required actions, approvals, and documentation are completed within established timelines.
• Support customer, corporate, FDA, and third-party audits by providing documentation and responding to requests.
• Monitor quality trends and communicate issues and improvement opportunities to Quality Management.
• Perform additional duties as directed by supervisor.