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).
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.
A High School Diploma or GED is required.
2 years or more experience in Pharmaceutical QA is 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.