Location: Piscataway,NJ, USA
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 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 record
* Monitor 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 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.