Quality Assurance Inspector II - 2nd Shift

Amneal

3d•Onsite

About The Position

The Quality Assurance Inspector II - 2nd Shift position is responsible for monitoring and ensuring that all incoming raw materials, packaging components, and returned goods are sampled, inspected, and tested to verify compliance with established specifications. This role also ensures that all phases of drug manufacturing adhere to specifications, and manages the receipt, inspection, release, and control of labels and outserts. The inspector plays a crucial role in ensuring quality compliance throughout the packaging process.

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
Successful completion of an OSHA-compliant Respirator Fit Test

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 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 as per manufacturing and packaging batch record instructions.
Prepare controlled/uncontrolled/packaged finished product samples for QC lab and QA retains.
Label 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.
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 processes.
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 before the next processing step.
Verify the 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 manage sample disposition.
Dispose of rejected material and returned drug products as per SOP.
Perform environmental monitoring according to established schedules.
Perform applicable testing and prepare reports for customer complaints.