Lead, Q.C. 1st Shift

Quality Assurance Manager

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.

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