Job 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:

• Perform in-process and final product quality analyses and inspection

• Execute Finished Product (FP) Testing and IP/FP Analytical Testing

• Interpret analytical results for accuracy, precision, and compliance

• Operate measuring devices, laboratory instruments, and testing equipment

• Apply approved analytical methods, operations, and specifications

• Support acceptance or rejection decisions for materials and products

• Identify ongoing quality issues and prevent production risks

• Audit and monitor manufacturing processes and quality outputs

• Conduct random sampling and testing of finished goods

• Review and maintain GMP documentation and analytical records

• Report manufacturing process deviations and product defects

Additional Responsibilities:

• Participate in method validation, verification, and transfer activities as required.

• Assist in updating and reviewing SOPs, specifications, and analytical procedures.

• 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.

Education:

• Bachelors Degree (BA/BS) B. Sc. - Required

• Master Degree (MS/MA) M. Sc. - Preferred

Experience:

• 3 years or more in 3 - 6 Years

Specialized Knowledge: Licenses: