Senior Quality Assurance Inspector - 2nd Shift

Amneal Pharmaceuticals LLC; United States; On-site; USD 36,000 - 43,000; Full time

Job summary

Amneal Pharmaceuticals LLC is seeking a QA Inspector II for the second shift (3:30pm - 12:00am, Mon-Fri) to monitor and ensure all incoming raw materials, packaging components, and returned goods are sampled, inspected, and tested to meet specifications. The role includes release activities, label control, and coordination with manufacturing for compliance during each packaging run.

The position requires High School or GED, 3+ years in QA, and an OSHA-compliant respirator fit test.

Qualifications

• High School or GED required.
• 3+ years in QA or related field.
• OSHA-compliant Respirator Fit Test required.

Responsibilities

• Inspect and monitor incoming raw materials, packaging components and returned goods for compliance with specifications.
• Review batch records and ensure documentation signatures, data integrity and reconciliation prior to next processing step.
• Coordinate with manufacturing and engineering teams to resolve quality issues in a timely manner.
• Generate and issue in-house labels in accordance with master batch records and process study protocols.
• Perform rinse and swab sampling for microbial verification and handle complaint samples for testing.

Education

High School or GED

Job description

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.

Education

• High School or GED - Required

Experience

• 3 years or more in 3 or more years' experience in QA or related field

Additional Requirement

This position requires successful completion of an OSHA-compliant Respirator Fit Test.

The hourly base salary for this position ranges from $26.00 to $31.00 per hour. Amneal ranges reflect the Company’s good faith estimate of base salary that 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, 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 helps you enjoy your career alongside life’s many other commitments and opportunities.