Quality Assurance Inspector II

Amneal

9d

About The Position

The Quality Assurance Inspector II monitors and ensures that incoming raw materials, packaging components, and returned goods are sampled, inspected, and tested where applicable to determine compliance with established specifications. The role also monitors drug manufacturing for compliance with specifications and receives, inspects, releases, and controls labels and outserts. It ensures quality compliance before, during, and after packaging runs.

The position performs all functions of a QA Inspector I and carries out inspections, sampling, testing, documentation, in-process checks, labeling controls, and warehouse and environmental compliance activities. Additional duties include reviewing engineering and batch records, verifying equipment functionality, maintaining retention samples, dispositioning rejected materials and returned products, conducting scheduled environmental monitoring, and supporting customer complaint investigations. Other duties may be assigned by management.

Requirements

• High school diploma or GED.
• At least 2 years of experience in QA or a related field.
• Good basic math knowledge.
• Excellent attention to detail.
• Ability to record observations that can help improve processes.

Responsibilities

• Inspect, sample, and test incoming raw materials, packaging components, and returned goods according to written procedures.
• Prepare samples for chemical and microbiological analysis when required and deliver them to the QC lab.
• Inspect and test packaging components using measuring devices such as scales, micrometers, and height gauges.
• Maintain detailed records of sampling, inspections, and testing.
• Assign and verify expiry and retest dates for GMP raw materials using vendor and in-house certificates of analysis.
• Collect packaged product samples for annual stability.
• Perform room, equipment, and packaging-line checks before each manufacturing stage, where applicable.
• Conduct in-process testing according to manufacturing and packaging batch record instructions.
• Prepare controlled, uncontrolled, and packaged finished-product samples for the QC lab and QA retains in accordance with documentation procedures.
• Maintain standard weights used for daily balance verification.
• Receive labeling components; perform visual examinations, counting, preliminary inspections, and sampling.
• Prepare labeling-component and outsert inspection reports; quarantine and release labels; and maintain incoming-component logs and inventory cards.
• Issue labeling components and outserts according to packaging orders and regularly monitor and audit the label room.
• Complete QA final labeled-product inspection reports and final line clearance, including labeling and packaging reconciliation paperwork.
• Ensure warehouse areas for quarantine, released, in-process, finished, packaged, returned, and rejected goods are properly isolated.
• Ensure rejected material generated during batch processing is properly isolated and accounted for in the batch record.
• Monitor facility and product environmental operating conditions.
• Review engineering records, including temperature and humidity data, calibration and preventive-maintenance records, pest-control records, and contractor-related functions.
• Review online batch records for complete signatures and entries and for actual reconciliation and yields before the next processing step begins.
• Verify the functionality of equipment and associated controls during batch runs.
• Maintain the retention sample room; monitor temperature and humidity; replace chart records according to schedule; review logs; and disposition samples.
• Disposition rejected materials and returned drug products according to SOPs.
• Perform environmental monitoring according to the established schedule, where applicable.
• Perform applicable testing and prepare reports for customer complaints.
• Perform other duties assigned by management.

Benefits

• Short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months.
• Health and insurance benefits for eligible positions.
• 401(k) matching contribution.
• Employee well-being programs.

What This Job Offers

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