QA Auditing Reviewer
Amneal Pharmaceuticals
August 11, 2026
On-site
Piscataway, NJ
Operations
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 disposition for each lot and make correct entries in JDE.
- Ensure batches placed on Hold or Reject are appropriately stored in designated limited access areas.
- Log RFT data in accordance with established QA processes.
- Load batch data into the APR database (if required).
- Perform timely reviews of QA In-Process Data.
- Communicate clearly and concisely, orally and in writing.
- Operate scientific calculators and personal computers.
Additional Responsibilities:
- Fill in for In-process QA inspectors when circumstances dictate.
Qualifications:
- Education: High School or GED (Required); Bachelor’s degree in related field (Preferred).
- Experience: 2+ years in Pharmaceutical QA, QC, or QM.
- Specialized Knowledge/Skills: Excellent knowledge of manufacturing processes from raw material receipt through finished goods packaging; comprehensive understanding of GMP standards (21 CFR Parts 210, 211, 820) and relevant ICH guidance.
Compensation/Benefits (as stated):
- Hourly rate: $22.00–$32.00/hour; short-term incentive and long-term incentive (restricted stock units) within first 12 months; 401(k) matching; health and insurance benefits.
- Thoroughly audit all production records (work order #1 and #2 for commercial and exhibit batches) and determine batch disposition (Release, Hold, Reject); physically perform disposition for each lot and make correct entries in JDE.
- Ensure batches placed on Hold or Reject are appropriately stored in designated limited access areas.
- Log RFT data in accordance with established QA processes.
- Load batch data into the APR database (if required).
- Perform timely reviews of QA In-Process Data.
- Communicate clearly and concisely, orally and in writing.
- Operate scientific calculators and personal computers.
Additional Responsibilities:
- Fill in for In-process QA inspectors when circumstances dictate.
Qualifications:
- Education: High School or GED (Required); Bachelor’s degree in related field (Preferred).
- Experience: 2+ years in Pharmaceutical QA, QC, or QM.
- Specialized Knowledge/Skills: Excellent knowledge of manufacturing processes from raw material receipt through finished goods packaging; comprehensive understanding of GMP standards (21 CFR Parts 210, 211, 820) and relevant ICH guidance.
Compensation/Benefits (as stated):
- Hourly rate: $22.00–$32.00/hour; short-term incentive and long-term incentive (restricted stock units) within first 12 months; 401(k) matching; health and insurance benefits.