Quality Assurance Inspector II -2nd Shift

Amneal • Piscataway Township, NJ

2d • $21 - $27

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, receives and controls labeling components, and verifies quality compliance before, during, and after each packaging run.

This position works the second-shift schedule, 3:00 p.m. to 11:30 p.m. Responsibilities include sampling and testing materials, preparing samples for laboratory analysis, inspecting packaging components, maintaining records, reviewing batch and engineering records, and monitoring manufacturing and packaging operations. The inspector also handles label and outsert controls, sample retention, environmental monitoring, and disposition of rejected materials and returned products.

The position requires a high school diploma or GED and at least two years of experience in QA or a related field. The hourly pay range is $21.00–$27.00. Eligible positions offer a flexible benefits program that includes health and insurance benefits and a 401(k) matching contribution. A short-term incentive opportunity, such as a bonus or performance-based award, may also be available within the first 12 months.

Requirements

• High school diploma or GED.
• At least two years of experience in QA or a related field.
• Good basic math knowledge.
• Excellent attention to detail.
• Ability to record observations for process improvement.
• Ability to work the second shift, 3:00 p.m. to 11:30 p.m.

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 laboratory.
• Inspect and test packaging components using measuring devices such as scales, micrometers, and height gauges; maintain detailed sampling, inspection, and testing records.
• Assign and verify expiration and retest dates for GMP raw materials using vendor and in-house certificates of analysis.
• Collect packaged-product samples for annual stability testing.
• Perform room, equipment, and packaging-line checks before manufacturing stages, as applicable, following written procedures.
• 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; 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 final labeled-product inspection reports and final line-clearance activities, including labeling and packaging reconciliation paperwork.
• Ensure warehouse areas are appropriately isolated for quarantined, released, in-process, finished, packaged, returned, and rejected materials or products.
• Ensure rejected material generated during batch processing is properly isolated and accounted for in batch records.
• 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 on schedule, review logs, and disposition samples.
• Disposition rejected material 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

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

What This Job Offers

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