Lead, Q.C. 1st Shift

- 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.