Quality Assurance Inspector II - 2nd Shift

Amneal • Brookhaven, NY

4d • $21 - $27 • Onsite

About The Position

This role monitors and ensures compliance with established specifications for incoming raw materials, packaging components, and returned goods through sampling, inspection, and testing. It also oversees all phases of drug manufacturing, label and outsert control, and quality compliance during packaging runs. The position involves detailed record-keeping, sample preparation for analysis, and conducting various checks and tests throughout the manufacturing and packaging processes. Additionally, it includes reviewing engineering records, batch records, and ensuring proper isolation and accountability of materials within the warehouse.

Requirements

• High School or GED - Required
• 2 years or more experience in QA or related field
• Good basic math knowledge
• Excellent attention to details
• Records observations for improving processes
• Successful completion of an OSHA-compliant Respirator Fit Test

Responsibilities

• Monitor and ensure all incoming raw materials, packaging components, and returned goods are sampled, inspected, and tested for compliance with established specifications.
• Monitor and ensure all phases of drug manufacturing are in compliance with established specifications.
• Receive, inspect, release, and control labels and outserts.
• Ensure quality compliance before, during, and after each packaging run.
• Perform inspection, sampling, and testing on 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.
• 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.
• Maintain incoming components log and corresponding inventory cards.
• Issue labeling components/outserts according to packaging order and monitor/audit the label room.
• Fill out the QA final labeled product inspection report, final line clearance, and labeling and packaging reconciliation paperwork.
• Ensure compliance of the warehouse area in terms of 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 reconciliation/yields.
• Verify functionality of all equipment and associated controls during the batch run.
• Maintain the retention sample room, monitor temperature and humidity, replace chart records, review logs, and disposition samples.
• Disposition of rejected material and returned drug products as per SOP.
• Perform environmental monitoring in accordance with established schedule.
• Perform applicable testing and prepare reports for customer complaints.
• Perform other duties as assigned by management.

Benefits

• Above-market, diverse and robust health and insurance benefits
• Significant 401(k) matching contribution
• Programs that help employees enjoy their career alongside life’s many other commitments and opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED