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Amneal New Jersey

QA Auditing Reviewer

Amneal New Jersey Piscataway Township, New Jersey, United States · $46K–$67K/yr

Pharmaceutical Manufacturing · 5,001-10,000 employees

6 h ago
qa Mid (2-5 yrs) Full-time United States
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About the role

The QA Auditing Reviewer is responsible for auditing production records to determine batch disposition and executing these decisions within the JDE system. They also manage the storage of held or rejected batches and perform in-process QA data reviews.

What they look for

QA Auditing Batch Disposition JDE GMP Standards 21 CFR Part 210 21 CFR Part 211 21 CFR Part 820 ICH Guidance Production Record Review Data Logging In-process QA Inspection Pharmaceutical Quality Assurance Manufacturing Processes Scientific Calculator Operation Technical Writing

Requirements

Candidates must have at least a High School diploma or GED and a minimum of 2 years of experience in Pharmaceutical QA, QC, or QM. A comprehensive understanding of GMP standards and manufacturing processes is required.

Benefits

Health Insurance Insurance Benefits 401k Matching Short-term Incentive Long-term Incentive Restricted Stock Units

Full description

Description:

This QA Auditing Reviewer role is responsible for thoroughly auditing production records, determining batch disposition (Release, Hold, Reject), and executing those decisions in systems like JDE while ensuring held or rejected batches are properly controlled and stored. It also logs and loads batch data into required databases, regularly audits QA in‑process data, and may fill in for in‑process QA inspectors when needed.

Essential Functions:

  • Thoroughly audit all production records (work order #1 and #2 for commercial and exhibit batches) and determine batch disposition (Release, Hold, Reject). Physically perform batch disposition for each lot of product produced, including making the correct entries in JDE.
  • Responsible for making sure Batches placed on Hold or Reject status are appropriately stored in their designated limited access areas.
  • Log RFT data in accordance with established QA Processes
  • Load batch data into the APR database (if required)
  • Communicating clearly and concisely, both orally and in writing.
  • Operating scientific calculators and personal computers
  • Performs timely reviews of QA In-Process Data

Additional Responsibilities:

  • Must be able to fill in for In-process QA inspectors when circumstances dictate

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.

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