Quality Assurance Inspector II - 2nd Shift

Description:

To monitor and ensure 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. To monitor and ensure all phases of drug manufacturing are in compliance with established specifications. To receive, inspect, release and control of labels and outserts. To ensure quality compliance before, during and after each packaging run.

Essential Functions:

• Perform inspections, sampling, and testing of all incoming raw materials, packaging components, and returned goods in accordance with detailed written procedures. Prepare and deliver samples for chemical and microbiological (where required) analysis to the QC lab.
• Inspect and test packaging components using scales, micrometers, height gauges, and other devices to verify conformance to specifications. Maintain accurate records of all sampling, inspections, and testing activities.
• Assign and verify expiry dates and retest dates for GMP raw materials based on vendor and in-house Certificates of Analysis (COA). Collect packaged product samples for annual stability testing.
• Conduct room, equipment, and packaging line checks prior to each stage of manufacturing, following written procedures. Perform in-process testing per manufacturing and packaging batch record instructions.
• Prepare controlled, uncontrolled, and packaged finished product samples for QC lab testing and QA retains, ensuring full documentation. Maintain standard weights required for daily balance verification.
• Manage labeling components, including receipt, visual inspection, counting, preliminary testing, and sampling. Prepare inspection reports, quarantine and release labels, and maintain incoming component logs and inventory cards.
• Issue labeling components/outserts per packaging order and conduct regular monitoring and auditing of the label room. Complete QA final labeled product inspection reports and perform final line clearances, including labeling and packaging reconciliation.
• Ensure warehouse compliance with isolation standards for Quarantine, Released, In-Process, Finished Product, Packaged Product, Returned Goods, and Rejected areas. Properly isolate and account for rejected materials during batch processing.
• Monitor facility and product environmental operating conditions.
• Review engineering records, including temperature/humidity data, calibration/PM records, pest control logs, and contractor-related functions.
• Review online batch records for completeness of signatures, entries, reconciliation, and yields prior to initiation of subsequent processing steps.
• Verify equipment functionality and associated controls during batch runs.
• Maintain retention sample room by monitoring temperature/humidity, replacing chart records on schedule, reviewing logs, and ensuring proper disposition of samples.

Additional Responsibilities:

• Disposition of rejected material and returned drug products as per SOP
• Performs environmental monitoring in accordance with established schedule (where applicable)
• Perform applicable testing and prepare report for customer complaints
• Other duties that management may from time to time assign.

Education:

• High School or GED - Required

Experience:

• 2 years or more in 2 or more years experience in QA or related field

Skills:

• High energy level and organizational skills. - Advanced
• A certain degree of creativity and latitude - Advanced
• 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 $27.00 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.