Manufacturing Quality Inspector

Position Summary

The Manufacturing Quality (MQ) Inspector’s responsibility will be to monitor production processes for compliance to cGMP standards. He/she will perform a variety of quality control checks to ensure appropriate utilization of equipment, commodities, product and procedures for the assigned production area. Conduct and document a variety of visual, functional and dimensional testing in support of commodity/product release – particularly in the bag fabrication, overwrap and packaging areas of production.

• Inspects materials, batch record documents and final products during the production process or off line (APQR, re‑inspection, batch records). Performs and records release functional and dimensional testing. Restarts automated equipment that stopped for quality issues.
• Evaluates products for defects and recognize unacceptable product. Makes decision regarding product conformity and determines if MQ batch record criteria is met.
• Performs testing on commodities and final product and determines acceptance according to specifications.
• Collects file samples, stability testing samples, and laboratory samples in accordance with established procedures.
• Inputs data (numerical/informational) into batch records, reports and electronic data bases. Recognizes unacceptable product. Monitors production lines for irregularities and reports to area supervisor, accordingly.
• Works with both internal and external customers. Shares information and provides feedback on material, operational, and mechanical related issues.
• Performs mathematical calculations such as adding, subtracting, multiplying and dividing and therefore must have working knowledge of mathematical applications.
• Uses good problem solving and interpersonal skills for effective communications. Follows up on activities to ensure quality is maintained. Assists in area improvements, department changes and meetings.
• Follows prescribed uniform and gowning requirements. Maintains a safe, orderly, clean work environment. Reports all accidents to the supervisor. Ensures all PPE (personal protective equipment) is used, as required.
• Adheres to cGMP guidelines, SOP’s and plant policies/guidelines. Assists in monitoring area for cGMP compliance.
• Perform other related duties or special assignments as directed by supervisor.

The Manufacturing Quality (MQ) Inspector’s responsibility will be to monitor production processes for compliance to cGMP standards. He/she will perform a variety of quality control checks to ensure appropriate utilization of equipment, commodities, product and procedures for the assigned production area. Conduct and document a variety of visual, functional and dimensional testing in support of commodity/product release – particularly in the bag fabrication, overwrap and packaging areas of production.

• Inspects materials, batch record documents and final products during the production process or off line (APQR, re‑inspection, batch records). Performs and records release functional and dimensional testing. Restarts automated equipment that stopped for quality issues.
• Evaluates products for defects and recognize unacceptable product. Makes decision regarding product conformity and determines if MQ batch record criteria is met.
• Performs testing on commodities and final product and determines acceptance according to specifications.
• Collects file samples, stability testing samples, and laboratory samples in accordance with established procedures.
• Inputs data (numerical/informational) into batch records, reports and electronic data bases. Recognizes unacceptable product. Monitors production lines for irregularities and reports to area supervisor, accordingly.
• Works with both internal and external customers.…