Quality Assurance Inspector II - 2nd Shift

Amneal

16h•Onsite

About The Position

The Quality Assurance Inspector II is responsible for monitoring and ensuring compliance with established specifications for incoming raw materials, packaging components, returned goods, and all phases of drug manufacturing. This role involves receiving, inspecting, releasing, and controlling labels and outserts, and ensuring quality compliance throughout packaging runs. The position also includes performing various checks, tests, and record-keeping to maintain product quality and regulatory compliance.

Requirements

High School or GED - Required
2 or more years of experience in QA or a related field
Good basic math knowledge
Excellent attention to detail
Ability to record observations for improving processes

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 GMP raw materials using vendor and in-house COAs.
Collect packaged product samples for annual stability studies.
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 orders and monitor/audit the label room.
Fill out 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 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, contractor-related functions).
Review online batch records for completeness of signatures, entries, and actual reconciliation/yields.
Verify functionality of all equipment and associated controls during batch runs.
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 the established schedule.
Perform applicable testing and prepare reports for customer complaints.
Perform other duties as assigned by management.