Quality Assurance Inspector II -2nd Shift

Amneal

1d

About The Position

The Quality Assurance Inspector II monitors and ensures that incoming raw materials, packaging components, returned goods, and all phases of drug manufacturing comply with established specifications. The role includes receiving, inspecting, releasing, and controlling labels and outserts, and ensuring quality compliance before, during, and after packaging runs. This position works the second shift, from 3:00 p.m. to 11:30 p.m.

The inspector samples and tests materials where applicable, prepares samples for laboratory analysis, performs inspections and in-process testing, and maintains detailed records. The role also supports label-room and warehouse controls, batch-record review, environmental monitoring, equipment verification, stability sampling, and disposition of rejected materials and returned drug products.

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.

Nice To Haves

• No preferred qualifications stated.

Responsibilities

• Perform all functions of a QA Inspector I.
• 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 laboratory.
• Inspect and test packaging components using measuring devices such as scales, micrometers, and height gauges.
• Maintain detailed records of sampling, inspections, and testing activities.
• 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 applicable manufacturing stages.
• Conduct in-process testing according to manufacturing and packaging batch-record instructions.
• Prepare controlled, uncontrolled, and packaged finished-product samples for the QC laboratory and QA retains, following documentation procedures.
• Maintain standard weights used for daily balance verification.
• Receive labeling components; perform visual examination, counting, preliminary inspection, and sampling.
• Prepare labeling-component and outsert inspection reports; quarantine and release labels; and maintain the incoming-components log and inventory cards.
• Issue labeling components and outserts according to packaging orders and regularly monitor and audit the label room.
• Complete the QA final labeled-product inspection report and final line clearance, including labeling and packaging reconciliation paperwork.
• Ensure warehouse areas properly isolate quarantined, released, in-process, finished, packaged, returned, and rejected goods.
• 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 as scheduled; 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.
• 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