Senior Quality Assurance Inspector - 2nd Shift
Amneal · Brookhaven
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.
Schedule:
2nd Shift 3:30pm - 12:00am Monday to Friday
Essential Functions:
- All requirements from Inspector II, Review of engineering records (temperature and humidity data calibration and PM records, Pest control records and contractor related functions)Review of online batch records in terms of completeness of signatures, entries, and actual reconciliation / yields prior to initiation of next processing step Verification of functionality of all the 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. plus the following:
- Monitor and release of Purified Water System
- Generates, proof read and issues "in-house" labels as in accordance with Process Study protocols and master batch records.
- performs rinse and swab sampling for microbial cleaning verification
- Handling complaint samples, visual inspection or retention / complaints samples, Batch record review for the receipt of complaint batches, collection of complaints / retention samples for analytical testing in case of complaint investigation
- Identification of gaps in the manufacturing and packaging equipment and assess the impact on the quality of product
- Coordination with manufacturing and engineering teams to resolve compliance issues in a timely manner
Additional Responsibilities:
- Performs rinse and swab sampling for microbial cleaning verification
- Handling complaint samples, visual inspection or retention / complaints samples, Batch record review for the receipt of complaint batches, collection of complaints / retention samples for analytical testing in case of complaint investigation
- Identification of gaps in the manufacturing and packaging equipment and assess the impact on the quality of product
- Coordination with manufacturing and engineering teams to resolve compliance issues in a timely manner
- Other duties that management may from time to time assign.
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 accommodations@amneal.com. Requests will be handled confidentially and in accordance with applicable laws.
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.More jobs at Amneal · Legal & Compliance jobs in Brookhaven, NY