Quality Assurance Inspector

About the role

The QA Inspector role involves ensuring compliance with established specifications across all phases of drug manufacturing, from raw materials to finished products. This role operates on a 12-hour rotating schedule, working from 6:00 PM to 6:30 AM, with every other weekend.

Responsibilities

• Perform Inspection, sampling and testing on all 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 such as scales, micrometers, and height gauges to ensure conformance to specifications.
• Maintain detailed records of sampling, inspections, and testing activities.
• Assign and verify expiry dates and retest dates for all GMP raw materials through vendor COA and in-house COA.
• Collect packaged product samples for annual stability testing.
• Perform room, equipment, and packaging line checks prior to each stage of manufacturing following detailed written procedures.
• Conduct in-process testing per manufacturing and packaging batch record instructions.
• Prepare controlled/uncontrolled/packaged finished product samples for the QC lab and retain QA samples, following detailed documentation procedures.
• Maintain standard weights required to perform daily verification of balances.
• Label component receipt, visual examination, counting, preliminary inspection and sampling.
• Prepare labeling components/outserts inspection reports; quarantine and release labels and maintain incoming components log and corresponding inventory cards.
• Issue labeling components/outserts according to packaging orders and regularly monitor and audit the label room.
• Fill out QA final labeled product inspection reports, final line clearance which includes labeling and packaging reconciliation paperwork.
• Ensure proper isolation of rejected material generated during batch processes and accountability in batch records.
• Monitor facility and product environmental operating conditions.
• Operate, maintain, and calibrate hardness testers, friabilators, weight variation systems, weighing scales and balances, label counting machines, and Kirby Lester tablet counters according to established schedules and maintain detailed calibration records.
• Collect samples to reassay bulk finished products before expiration.
• Perform visual inspections and prepare reports of all products for APRO.
• Perform other duties as assigned by management.

Qualifications

• High School or GED - Required
• Experience: 1 year or more in QA or related field
• Specialized Knowledge: Good basic math knowledge and excellent attention to details. Records observations for improving processes.

Skills

• Attention to detail
• Mathematical proficiency
• Record-keeping
• Quality assurance
• Equipment operation and maintenance
• Calibration and testing
• Inventory management
• Labeling and packaging
• Environmental monitoring

Benefits

Amneal offers a comprehensive benefits program that includes:

• Above-market, diverse and robust health and insurance benefits
• A significant 401(k) matching contribution
• Employee well-being programs

Pay

The hourly rate for this position ranges from $19.50 to $23.50 per hour. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months.

Schedule

This role operates on a 12-hour rotating schedule, working from 6:00 PM to 6:30 AM, with every other weekend.