QA Auditor I at Amneal Pharmaceuticals LLC (J0P) in Branchburg, New Jersey

Job Description:

Description:

The QA Auditor I thoroughly audits 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.

• Resposible 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 Diploma or GED:  Required

Experience:

• 2 years or more experience 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.