- 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
- Must be able to fill in for In-process QA inspectors when circumstances dictate
- High School or GED - Required
- 2 years or more in Pharmaceutical QA - Required
- 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
- 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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QA Auditor I - Piscataway, United States - Amneal Pharmaceuticals
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
Additional Responsibilities
Education
Work Experience
Skills and Abilities
Specialized Knowledge