QA Auditing Reviewer
About the role
This QA Auditing Reviewer role is responsible for thoroughly auditing production records, determining batch disposition (Release, Hold, Reject), and executing those decisions in systems like JDE while ensuring held or rejected batches are properly controlled and stored. It also logs and loads batch data into required databases, regularly audits QA in-process data, and may fill in for in-process QA inspectors when needed.
Responsibilities
- 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 in accordance with established QA Processes
- Load batch data into the APR database (if required)
- Communicating clearly and concisely, both orally and in writing.
- Operating scientific calculators and personal computers
- Performing timely reviews of QA In-Process Data
Requirements
Education: High School or GED - Required Bachelors Degree in Related Field - Preferred
Experience: 2 years or more in Pharmaceutical QA, QC or QM
Specialized Knowledge: Excellent knowledge of manufacturing processes from Raw Material Receipt through finished goods packaging Comprehensive understanding of GMP standards, including 21 CFR Parts 210, 211, 820, and relevant ICH guidance.
Qualifications
Must be able to fill in for In-process QA inspectors when needed
Skills
None specified
Benefits
None specified
Pay
Not specified
Schedule
Not specified