QA Auditor I at Amneal Pharmceutical LLC

Posted in Science 12 days ago.

This job brought to you by eQuest

Type: Full-Time
Location: Piscataway, New Jersey





Job Description:

Description:

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:


  • A High School or GED is required.

Experience:


  • 2 years or more in Pharmaceutical QA is required.

Skills:


  • 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.