Senior Quality Assurance Inspector - 2nd Shift

HireLifeScience; Town of Brookhaven (NY); On-site; USD 65,000 - 90,000; Full time

Job summary

Amneal is seeking a QA/Inspections professional to monitor sampling, inspection, and testing of raw materials and packaging components, ensuring compliance with specifications throughout manufacturing and packaging runs. You will review batch records, maintain retention samples, and coordinate with engineering to resolve issues.

Required is a high school diploma or GED, and at least 3 years of QA or related experience.

Qualifications

• High School diploma or GED required.
• Minimum 3 years in QA or related field.

Responsibilities

• Monitor and ensure sampling, inspection and testing of incoming materials and packaging to meet specifications.
• Verify and release labels and outserts; ensure quality compliance during each packaging run.
• Review batch records for completeness, signatures, and reconciliation prior to next steps.
• Maintain retention sample room and monitor temperature/humidity; replace chart records per schedule.
• Coordinate with manufacturing and engineering to resolve compliance issues in a timely manner.
• Handle complaint samples and conduct analyses as needed for investigations.
• Identify gaps in equipment or processes and assess impact on product quality.

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.

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 reconcilaiton / yields prior to initiation of next processing stepVerification of functionality of all the equipment and associated controls during the batch runMaintenance of retention sample room and monitoring of temperature and humidity, replacement fo 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

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 [e-mail] . Requests will be handled confidentially and in accordance with applicable laws.