Senior Quality Assurance Inspector - 1st Shift

Amneal • Yaphank, NY

1d • $26 - $31 • Onsite

About The Position

This role monitors and ensures all incoming raw materials, packaging components, and returned goods are sampled, inspected, and tested for compliance with established specifications. It also ensures all phases of drug manufacturing comply with specifications, and manages the receipt, inspection, release, and control of labels and outserts. The position ensures quality compliance before, during, and after each packaging run.

Requirements

• High School or GED - Required
• 3 or more years' experience in QA or related field
• Successful completion of an OSHA-compliant Respirator Fit Test.

Responsibilities

• 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.
• Monitor and ensure all phases of drug manufacturing are in compliance with established specifications.
• Receive, inspect, release and control of labels and outserts.
• Ensure quality compliance before, during and after each packaging run.
• Review 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.
• Monitor and release of Purified Water System.
• Generates, proof reads 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.
• Other duties that management may from time to time assign.

Benefits

• Above-market, diverse and robust health and insurance benefits
• Significant 401(k) matching contribution
• Programs that help employees enjoy their career alongside life's many other commitments and opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED