QA Auditing Reviewer

Amneal Pharmaceuticals, Inc.
  • Piscataway, NJ
  • Autofill and Review
30+ days ago

Job 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

Numbers & Facts

LocationPiscataway, NJ

Skills

  • Auditingunmatched
  • Calculatorsunmatched
  • Communication Skillsunmatched
  • Data Processingunmatched
  • Java IDE (Integrated Development Environments)unmatched
  • Process Developmentunmatched
  • Quality Assuranceunmatched
  • Quality Assurance Methodologyunmatched
  • Time Managementunmatched

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