Quality Assurance Inspector II - 2nd Shift

About the Role

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 meet 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.

Schedule

2nd Shift: 3:30 PM - 12:00 AM, Monday to Friday

Responsibilities

• Perform inspection, sampling, and testing of incoming raw materials, packaging components, and returned goods following detailed procedures.
• Prepare samples for chemical and microbiological analysis and deliver them to the QC lab.
• Inspect and test packaging components using measuring devices like scales, micrometers, and height gauges.
• Maintain detailed records of sampling, inspections, and testing activities.
• Assign and verify expiry dates and retest dates for GMP raw materials using vendor COA and in-house COA.
• Collect packaged product samples for annual stability.
• Perform room, equipment, and packaging line checks prior to each manufacturing stage.
• 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 balance verification.
• Handle labeling component receipt, visual examination, counting, preliminary inspection, and sampling.
• Prepare labeling components/outserts inspection reports and manage label quarantine, release, and inventory.
• Issue labeling components/outserts according to packaging orders and monitor the label room.
• Complete QA final labeled product inspection reports and packaging reconciliation paperwork.
• Ensure proper isolation of materials in the Warehouse area (Quarantine, Released, In-Process, Finished Product, Packaged Product, Returned Goods, Rejected areas).
• Monitor facility and product environmental operating conditions.
• Review engineering records (temperature, humidity, calibration, PM records, pest control, contractor functions).
• Verify online batch records for completeness and accuracy before the next processing step.
• Verify equipment functionality and associated controls during batch runs.
• Maintain the retention sample room, monitor temperature and humidity, and manage chart records.

Additional Responsibilities

• Dispose of rejected material and returned drug products per SOP.
• Perform environmental monitoring as scheduled.
• Conduct testing and prepare reports for customer complaints.
• Other duties as assigned by management.

Qualifications

• Education: High School or GED – Required
• Experience: 2+ years in QA or related field
• Specialized Knowledge: Good basic math skills and excellent attention to detail. Records observations for process improvement.

Additional Requirement

Successful completion of an OSHA-compliant Respirator Fit Test is required.

Pay

The hourly base salary for this position ranges from $21.00 to $27.00 per hour. Individual compensation will be determined based on qualifications, geographic location, and relevant skills.

Benefits

Amneal offers a comprehensive, flexible, and competitive benefits program, including above-market health and insurance benefits, a significant 401(k) matching contribution, and programs to support work-life balance.