QA Auditor I

4 months ago

Piscataway, United States Amneal Pharmaceuticals Full time

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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