Responsibilities:
- Inspect, sample, and test (where applicable) incoming raw materials, packaging components, and returned goods to ensure compliance with established specifications.
- Monitor all phases of drug manufacturing for compliance; receive, inspect, release, and control labels and outserts before, during, and after packaging runs.
- Perform room, equipment, and packaging line checks prior to manufacturing stages; conduct in-process testing per batch record instructions.
- Prepare controlled/uncontrolled/packaged finished product samples for QC lab and QA retains.
- Handle labeling component receipt: visual examination, counting, preliminary inspection, sampling; prepare inspection reports; quarantine/release labels; maintain incoming component logs and inventory cards; monitor and audit the label room.
- Complete QA final labeled product inspection reports and final line clearance (including labeling and packaging reconciliation).
- Ensure proper warehouse isolation of quarantine, released, in-process, finished/packaged, returned goods, and rejected areas; isolate rejected material and ensure accountability in batch records.
- Monitor facility and product environmental operating conditions.
Additional responsibilities:
- Operate, maintain, and calibrate QA equipment (hardness tester, friabilator, weight variation system, scales/balances, label counting machine, Kirby Lester tablet counters) and maintain calibration records.
- Collect samples to reassay bulk finished product before expiration; prepare APR product inspection reports; work in a contained manufacturing area; other duties as assigned.
Qualifications:
- High School or GED (required)
- 1+ year in QA or related field (preferred/required as stated)
- Good basic math and excellent attention to detail; ability to record observations to improve processes.
- OSHA-compliant respirator fit test (required).
Benefits/Compensation (as stated): $19.50β$23.50 per hour base salary.
Application instructions: Contact accommodations@amneal.com for reasonable accommodation requests during the application/hiring process.