Description:
The position is responsible for in-process and final product quality analyses and inspection in compliance with approved standards and regulatory requirements. The role involves interpreting and evaluating analytical results for accuracy and precision against established specifications. The role uses measuring devices, testing equipment, predefined methods, operations, setups, and specifications to support acceptance or rejection of materials and products. The position identifies ongoing quality issues, prevents potential production problems, and recommends improvements. The role audits, monitors, and determines the quality of manufacturing processes and outputs, performs random testing of finished goods, and reports manufacturing process deviations and product defects, ensuring data integrity, GMP compliance, and regulatory adherence.
Essential Functions:
Additional Responsibilities:
- Participate in method validation, verification, and transfer activities as required.
- Contribute to continuous improvement initiatives in the QC department.
- Report any out-of-specification (OOS) or out-of-trend (OOT) results promptly to the supervisor.
- Support cross-functional departments such as QA, Production, and Regulatory Affairs as needed.
