Quality Assurance Inspector

Description:

The QA Inspector monitors and ensures all incoming raw materials, packaging components and returned goods are sampled, inspected and tested (where applicable) for the purpose of determining compliance with established specifications. The QA Inspector must monitor and ensure all phases of drug manufacturing are in compliance with established specifications; receive, inspect, release and control of labels and outserts, to ensure quality compliance before, during and after each packaging run.

Essential Functions:

• Perform inspection, sampling, and testing of incoming raw materials, packaging components, and returned goods per written procedures.
• Prepare samples for chemical and microbiological analysis and deliver them to the QC lab.
• Inspect and test packaging components using measuring devices (e.g., scales, micrometers, height gauges) to ensure specification compliance.
• Maintain detailed records of all sampling, inspection, and testing activities.
• Assign and verify expiry and retest dates for GMP raw materials using vendor and in-house Certificates of Analysis (COA).
• Collect packaged product samples for annual stability studies.
• Conduct room, equipment, and packaging line checks before each manufacturing stage.
• Perform in-process testing as per manufacturing and packaging batch record instructions.
• Prepare finished product samples for QC lab and QA retains, following documentation protocols.
• Maintain standard weights for daily balance verification.
• Label component receipt: visual examination, counting, preliminary inspection, and sampling.
• Prepare inspection reports for labeling components/outserts; manage quarantine and release labels, and maintain logs and inventory cards.
• Issue labeling components/outserts per packaging orders; monitor and audit label room activities.
• Complete QA final labeled product inspection reports and final line clearance, including reconciliation paperwork.
• Ensure warehouse compliance: proper isolation of Quarantine, Released, In-Process, Finished, Packaged, Returned, and Rejected goods.
• Isolate and document rejected materials during batch processes, ensuring accountability in batch records.
• Monitor facility and product environmental operating conditions.

Additional Responsibilities:

• Operate, maintain and calibrate Hardness tester, Fibrillatory, Weight Variation system, weighing scales and balances, label counting machine, and Kirby Lester tablet counters according to established schedules and maintain detailed calibration records
• Collection of samples to reassay bulk finished product before expiration
• Work in a Contained Manufacturing area/facility following all precautions and procedures
• Visual inspection and preparation of report of all products for APR
• Other duties as assigned by management.

Education:

• High School or GED - Required

Experience:

• 1 year or more in 1 year in QA or related field

Skills:

• High energy level and organizational skills. - Advanced
• A certain degree of creativity and latitude is required. - Intermediate
• Basic computer skills (Word and Excel ) - Intermediate

Specialized Knowledge:

• Good basic math knowledge and excellent attention to details.
• Records observations for improving processes.

The hourly rate for this position ranges from $19.00 to $23.00 per hour. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, as well as a long-term incentive award, such as restricted stock units, with this position within the first 12 months. Amneal ranges reflect the Company’s good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.

Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.