QA Auditing Reviewer

Amneal

18h • Onsite

About The Position

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.

Requirements

• High School or GED - Required
• 2 years or more in Pharmaceutical QA, QC or QM
• 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.

Nice To Haves

• Bachelors Degree in Related Field - Preferred

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
• Performs timely reviews of QA In-Process Data

Benefits

• short-term incentive opportunity, such as a bonus or performance-based award
• long-term incentive award, such as restricted stock units
• comprehensive, flexible and competitive benefits program
• above-market, diverse and robust health and insurance benefits
• significant 401(k) matching contribution
• programs that help you enjoy your career alongside life’s many other commitments and opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED