Quality Assurance Inspector II - Night Shift

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 All Functions of QA Inspector I: Perform Inspection, sampling and testing where applicable on all incoming raw materials, packaging components and returned goods following detailed written procedures. Preparation of samples for chemical and microbiological (where required) analysis and delivering them to the QC lab. Inspection and test of packaging components utilizing various measuring devices such as scales, micrometers and height gauges to determine conformance to specifications. Maintain detailed records of sampling, inspections and testing activities. Assigning and verification of expiry date and retest date for all GMP raw materials through vendor COA and in‑house COA; collection of packaged product samples for annual stability. Perform room, equipment, and packaging line checks (where applicable) prior to each stage of manufacturing following detailed written procedures and conduct in‑process testing per manufacturing and packaging batch record instructions. Prepare controlled/uncontrolled/packaged finished product samples for QC lab and QA retains, following detailed documentation procedures. Maintain standard weights required to perform daily verification of balances. Labeling component receipt, visual examination, counting, preliminary inspection and sampling. Preparation of 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 order and regular monitoring and auditing of label room. Fill out the QA final labeled product inspection report, final line clearance which includes labeling and packaging reconciliation paperwork. Compliance of warehouse area in terms of isolation of quarantine, released, in‑process, finished product, packaged product, returned goods and rejected areas. Ensure the proper isolation of rejected material generated during batch process and accountability in the batch record. Monitor facility and product environmental operating conditions. Review engineering records (temperature and humidity data, calibration, preventive maintenance records, pest control records, and contractor related functions). Review online batch records for completeness of signatures, entries, and actual reconciliation/yields prior to initiation of next processing step. Verification of functionality of all equipment and associated controls during the batch run. Maintenance of retention sample room and monitoring of temperature and humidity, replacement of chart records as per schedule, review of log and disposition of samples. Additional Responsibilities Disposition of rejected material and returned drug products as per SOP. Perform environmental monitoring in accordance with established schedule (where applicable). Perform applicable testing and prepare report for customer complaints. Other duties that management may assign from time to time. Qualifications Education High School or GED – Required. Experience 2+ years experience in QA or a related field. Specialized Knowledge Good basic math knowledge and excellent attention to detail. Records observations for improving processes. Compensation and Benefits The hourly rate for this position ranges from $20.00 to $26.00 per hour. Amneal offers a short‑term incentive opportunity, such as a bonus or performance‑based award, within the first 12 months. An extensive benefits program is available, including health and insurance benefits and a 401(k) matching contribution. Employees may also participate in wellness programs. About Us Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at View email address on click.appcast.io. Requests will be handled confidentially and in accordance with applicable laws. #J-18808-Ljbffr Amneal Pharmaceuticals