Amneal Pharmaceuticals

Senior Quality Assurance Inspector - 1st Shift

Amneal Pharmaceuticals  •  $26 - $31/hr  •  New York (Onsite)  •  3 days ago
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Job 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:

1st Shift 7:00am - 3:30pm 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 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

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.

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.

Amneal Pharmaceuticals

About Amneal Pharmaceuticals

Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.

Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions.

Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam.

Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or drugsafety@amneal.com. If you are currently experiencing a life-threatening event, please immediately contact 911.

Industry
Chemicals & Materials
Company Size
5,001-10,000 employees
Headquarters
Bridgewater, New Jersey
Year Founded
2002
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