QA Auditing Reviewer

Job Overview This QA Auditing Reviewer role is responsible for thoroughly auditing production records, determining batch disposition (Release, Hold, Reject), and executing those decisions in systems such as JDE. The role ensures held or rejected batches are properly controlled and stored, 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. 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. Ensure 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. Communicate clearly and concisely, both orally and in writing. Operate scientific calculators and personal computers. Perform timely reviews of QA in‑process data. Additional Responsibilities Fill in for in‑process QA inspectors when needed. Education High School or GED – Required Bachelor’s Degree in a related field – Preferred Experience Minimum of 2 years 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. Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at View email address on click.appcast.io. Requests will be handled confidentially and in accordance with applicable laws. #J-18808-Ljbffr Amneal Pharmaceuticals