Quality Assurance Inspector II -2nd Shift

To monitor and ensure all incoming raw materials, packaging components, and returned goods are sampled, inspected, and tested (where applicable) for compliance with established specifications. To monitor and ensure all phases of drug manufacturing comply with established specifications. Responsibilities include receiving, inspecting, releasing, and controlling labels and outserts, as well as ensuring quality compliance before, during, and after each packaging run.

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 (where required) and deliver them to the QC lab.
• Inspect and test packaging components using measuring devices such as scales, micrometers, and height gauges to determine conformance to specifications.
• Maintain detailed records of sampling, inspections, and testing activities.
• Assign and verify expiry and retest dates for all GMP raw materials through vendor COA and in-house COA.
• Collect packaged product samples for annual stability testing.
• Perform room, equipment, and packaging line checks 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.
• Maintain standard weights required for daily verification of balances.
• Handle labeling component receipt, visual examination, counting, preliminary inspection, and sampling.
• Prepare labeling components/outserts inspection reports; quarantine and release labels while maintaining incoming components logs and inventory cards.
• Issue labeling components/outserts according to packaging orders and regularly monitor and audit the label room.
• Complete QA final labeled product inspection reports, final line clearance, and labeling/packaging reconciliation paperwork.
• Ensure compliance in the warehouse area for isolation of Quarantine, Released, In-Process, Finished Product, Packaged Product, Returned Goods, and Rejected materials.
• Properly isolate rejected material generated during batch processes and ensure accountability in the batch record.
• Monitor facility and product environmental operating conditions.
• Review engineering records (temperature, humidity, calibration, PM records, pest control, and contractor-related functions).
• Review online batch records for completeness of signatures, entries, and reconciliation/yields before initiating the next processing step.
• Verify functionality of all equipment and associated controls during batch runs.
• Maintain the retention sample room, monitor temperature and humidity, replace chart records as scheduled, review logs, and dispose of samples.
• Dispose of rejected material and returned drug products as per SOP.
• Perform environmental monitoring in accordance with established schedules (where applicable).
• Perform applicable testing and prepare reports for customer complaints.
• Complete other duties as assigned by management.

Requirements

• High School diploma or GED (required).
• 2+ years of experience in QA or a related field.
• Good basic math knowledge and excellent attention to detail.
• Ability to record observations for process improvement.

Pay

The hourly rate for this position ranges from $21.00 to $27.00 per hour. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months.

Benefits

Amneal provides a comprehensive, flexible, and competitive benefits program, including above-market health and insurance benefits, a significant 401(k) matching contribution, and programs to support employee well-being.

Schedule

This position requires working a 2nd shift schedule: 3:00 PM to 11:30 PM.