Quality Assurance Inspector II - Night Shift

Amneal•Piscataway, NJ

5d•$20 - $26•Onsite

About The Position

The Quality Assurance Inspector II will monitor and ensure all incoming raw materials, packaging components, and returned goods are sampled, inspected, and tested (where applicable) to determine compliance with established specifications. This role also ensures all phases of drug manufacturing comply with established specifications, and is responsible for receiving, inspecting, releasing, and controlling labels and outserts. The inspector ensures quality compliance before, during, and after each packaging run.

Requirements

All Functions of QA Inspector I
Experience with inspection, sampling, and testing of incoming raw materials, packaging components, and returned goods.
Experience with preparation of samples for chemical and microbiological analysis.
Experience with inspection and testing of packaging components utilizing various measuring devices (scales, micrometers, height gauges).
Ability to maintain detailed records of sampling, inspections, and testing activities.
Experience assigning and verifying expiry date and retest date for GMP raw materials.
Experience collecting packaged product samples for annual stability.
Experience performing room, equipment, and packaging line checks.
Experience conducting in-process testing per manufacturing and packaging batch record instructions.
Experience preparing controlled/uncontrolled/packaged finished product samples for QC lab and QA retains.
Experience maintaining standard weights for daily verification of balances.
Experience with labeling component receipt, visual examination, counting, preliminary inspection, and sampling.
Experience preparing labeling components/outserts inspection reports.
Experience quarantining and releasing labels and maintaining incoming components log and inventory cards.
Experience issuing labeling components/outserts according to packaging order.
Experience filling out QA final labeled product inspection reports and final line clearance.
Knowledge of warehouse area compliance regarding isolation of different material types.
Experience ensuring proper isolation of rejected material and accountability in batch records.
Experience monitoring facility and product environmental operating conditions.
Experience reviewing engineering records (temperature, humidity, calibration, PM, Pest control).
Experience reviewing online batch records for completeness.
Experience verifying functionality of equipment and controls during batch runs.
Experience maintaining retention sample rooms, monitoring temperature and humidity, and managing chart records.
Experience with disposition of rejected material and returned drug products.
Experience performing environmental monitoring.
Experience performing applicable testing and preparing reports for customer complaints.

Responsibilities

Perform inspection, sampling, and testing on all incoming raw materials, packaging components, and returned goods following detailed written procedures.
Prepare samples for chemical and microbiological analysis and deliver them to the QC lab.
Inspect and test packaging components using various measuring devices to determine conformance to specifications.
Maintain detailed records of sampling, inspections, and testing activities.
Assign and verify expiry dates and retest dates for all GMP raw materials.
Collect packaged product samples for annual stability.
Perform room, equipment, and packaging line checks prior to each stage of manufacturing.
Conduct in-process testing per manufacturing and packaging batch record instructions.
Prepare controlled/uncontrolled/packaged finished product samples for QC lab and QA retains.
Maintain standard weights required to perform daily verification of balances.
Perform labeling component receipt, visual examination, counting, preliminary inspection, and sampling.
Prepare labeling components/outserts inspection reports; quarantine and release labels and maintain incoming components log and corresponding inventory cards.
Issue labeling components/outserts according to packaging order and regularly monitor and audit the label room.
Fill out the QA final labeled product inspection report, final line clearance, which includes labeling and packaging reconciliation paperwork.
Ensure compliance of the 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.
Review engineering records (temperature and humidity data, calibration and PM records, Pest control records, and contractor-related functions).
Review online batch records for completeness of signatures, entries, and actual reconciliation/yields prior to initiation of the next processing step.
Verify functionality of all equipment and associated controls during the batch run.
Maintain the retention sample room, monitor temperature and humidity, replace chart records as per schedule, review logs, and disposition samples.
Disposition of rejected material and returned drug products as per SOP.
Perform environmental monitoring in accordance with established schedule (where applicable).
Perform applicable testing and prepare reports for customer complaints.
Perform other duties as assigned by management.