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Piscataway

    QA Auditor I - Piscataway, United States - Amneal Pharmaceuticals

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    Full time
    Description

    Job Summary

    Thoroughly audit all production records (work order #1 and #2 for commercial and exhibit batches) and determine batch disposition (Release, Hold, Reject)

    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 as required by Management
  • Load batch data into the APR database (if required)
  • Communicating clearly and concisely, both orally and in writing.
  • Operating scientific calculators and personal computers
  • Audit QA in-process data regularly and timely
  • Additional Responsibilities

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

  • High School or GED - Required
  • Work Experience

  • 2 years or more in Pharmaceutical QA - Required
  • Skills and Abilities

  • Excellent organizational skills with proficiency in computers. - Beginner
  • Ability to produce sufficient work within a stipulated time frame. - Beginner
  • High energy level and organizational skills. - Beginner
  • No unusual physical or mental demands or work conditions - Beginner
  • Specialized Knowledge

  • Excellent knowledge of manufacturing processes from Raw Material Receipt through finished goods packaging
  • Thorough understanding and familiarity with GMP regulations including 21 CFR 210 and 211, ICH guidelines

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