Quality Assurance Inspector II - 2nd Shift

Amneal•Piscataway, NJ

1d•$21 - $27•Onsite

About The Position

The Quality Assurance Inspector II is responsible for monitoring and ensuring that all incoming raw materials, packaging components, and returned goods meet established specifications through sampling, inspection, and testing. This role also ensures that all phases of drug manufacturing comply with established specifications. Additionally, the inspector handles the receipt, inspection, release, and control of labels and outserts, ensuring quality compliance before, during, and after each packaging run.

Requirements

Monitor and ensure 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.
Monitor and ensure all phases of drug manufacturing are in compliance with established specifications.
Receive, inspect, release and control of labels and outserts.
Ensure quality compliance before, during and after each packaging run.
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 perform 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.
Review of engineering records (temperature and humidity data calibration and PM records, Pest control records and contractor related functions)
Review of online batch records in terms of completeness of signatures, entries, and actual reconciliation / yields prior to initiation of next processing step
Verification of functionality of all the equipment and associated controls during the batch run
Maintenance of retention sample room and monitoring of temperature and humidity, replacement of chart records as per schedule, review of log and disposition of samples.
Disposition of rejected material and returned drug products as per SOP
Performs environmental monitoring in accordance with established schedule (where applicable)
Perform applicable testing and prepare report for customer complaints

Responsibilities

Perform inspection, sampling, and testing of 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 using vendor and in-house COAs.
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 for 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 monitor/audit the label room.
Complete the QA final labeled product inspection report, final line clearance, including labeling and packaging reconciliation paperwork.
Ensure compliance of warehouse areas, including isolation of Quarantine, Released, In-Process, Finished Product, Packaged Product, Returned Goods, and Rejected areas.
Ensure proper isolation and accountability of rejected material generated during batch process.
Monitor facility and product environmental operating conditions.
Review engineering records (temperature and humidity data, calibration and PM records, pest control records, contractor-related functions).
Review online batch records for completeness of signatures, entries, and reconciliation/yields before the next processing step.
Verify the functionality of all equipment and associated controls during the batch run.
Maintain the retention sample room, monitor temperature and humidity, replace chart records, review logs, and disposition samples.
Dispose of rejected material and returned drug products as per SOP.
Perform environmental monitoring in accordance with established schedule.
Perform applicable testing and prepare reports for customer complaints.
Perform other duties as assigned by management.