Description:

The QA Inspector I plays an important role in supporting our commitment to quality by overseeing the sampling, inspection and testing of incoming raw materials, packaging components and returned goods to ensure they meet established specifications. This role also supports quality oversight throughout all phases of drug manufacturing and helps maintain compliance at every step. In addition, the QA Inspector I is responsible for receiving, inspecting, releasing and controlling labels and outserts, as well as ensuring quality standards are upheld before, during and after each packaging run. This role follows a 12-hour rotating schedule, working from 6:00 PM to 6:30 AM

Essential Functions:

Perform Inspection, sampling and testing where applicable on all incoming raw materials, packaging components and returned goods following detailed written procedures. Preparation of samples for chemical and microbiological (where required) analysis and delivering them to the QC lab. Inspection and test of packaging components utilizing various measuring devices such as scales, micrometers and height gauges to determine conformance to specifications. Maintaining detailed records of sampling, inspections and testing activities. Assigning and verification of expiry date and retest date for all the GMP raw materials through vendor COA and in-house COA. Collection of packaged product samples for annual stability.Perform room, equipment, and packaging line checks (where applicable) prior to each stage of manufacturing following detailed written procedures. Conduct in process testing per manufacturing and packaging batch record instructions. Prepare controlled / uncontrolled / packaged finished product samples for QC lab and QA retains, following detailed documentation procedures. Maintenance of standard weights required to perfomr daily verification of balances.Labeling component receipt, visual examination, counting, preliminary inspection and sampling. Preparation of labeling components/outserts inspection reports; quarantine and release labels and maintaining incoming components log and corresponding inventory cards. Issuance of labeling components/outserts according to packaging order and regular monitoring and auditing of label room. Fill out the QA final labeled product inspection report, final line clearance which includes labeling and packaging reconciliation paperwork.Compliance of Warehouse area in terms of Isolation of Quarantine, Released, In-Process, Finished Product, Packaged Product, Returned Goods, and Rejected areas.Ensure the proper isolation of rejected material generated during batch process and accountability in the batch recordMonitor facility and product environmental operating conditions

Additional Responsibilities:

Operate, maintain and calibrate Hardness tester, Friabilitor, Weight Variation system, weighing scales and balances, label counting machine, and Kirby Lester tablet counters according to established schedules and maintain detailed calibration recordsCollection of samples to reassay bulk finished product before expirationWork in a Contained Manufacturing area/facility following all precautions and proceduresVisual inspection and preparation of report of all products for APROther duties as assigned by management.

 

Additional Requirement: 

This position requires successful completion of an OSHA-compliant Respirator Fit Test