"Alerted.org

Description:

The QA Inspector monitors and ensures all incoming raw materials, packaging components and returned goods are sampled, inspected and tested (where applicable) for the purpose of determining compliance with established specifications. The QA Inspector must monitor and ensure all phases of drug manufacturing are in compliance with established specifications; receive, inspect, release and control of labels and outserts, to ensure quality compliance before, during and after each packaging run.

Essential Functions:

+ Perform inspection, sampling, and testing of incoming raw materials, packaging components, and returned goods per written procedures.

+ Prepare samples for chemical and microbiological analysis and deliver them to the QC lab.

+ Inspect and test packaging components using measuring devices (e.g., scales, micrometers, height gauges) to ensure specification compliance.

+ Maintain detailed records of all sampling, inspection, and testing activities.

+ Assign and verify expiry and retest dates for GMP raw materials using vendor and in-house Certificates of Analysis (COA).

+ Collect packaged product samples for annual stability studies.

+ Conduct room, equipment, and packaging line checks before each manufacturing stage.

+ Perform in-process testing as per manufacturing and packaging batch record instructions.

+ Prepare finished product samples for QC lab and QA retains, following documentation protocols.

+ Maintain standard weights for daily balance verification.

+ Label component receipt: visual examination, counting, preliminary inspection, and sampling.

+ Prepare inspection reports for labeling components/outserts; manage quarantine and release labels, and maintain logs and inventory cards.

+ Issue labeling components/outserts per packaging orders; monitor and audit label room activities.

+ Complete QA final labeled product inspection reports and final line clearance, including reconciliation paperwork.

+ Ensure warehouse compliance: proper isolation of Quarantine, Released, In-Process, Finished, Packaged, Returned, and Rejected goods.

+ Isolate and document rejected materials during batch processes, ensuring accountability in batch records.

+ Monitor facility and product environmental operating conditions.

Additional Responsibilities:

+ Operate, maintain and calibrate Hardness tester, Fibrillatory, Weight Variation system, weighing scales and balances, label counting machine, and Kirby Lester tablet counters according to established schedules and maintain detailed calibration records

+ Collection of samples to reassay bulk finished product before expiration

+ Work in a Contained Manufacturing area/facility following all precautions and procedures

+ Visual inspection and preparation of report of all products for APR

+ Other duties as assigned by management.