QA Batch Disposition & Audit Specialist

Amneal Pharmaceuticals; Newtown (NJ); On-site; USD 30,000 - 44,000; Full time

Job summary

Amneal Pharmaceuticals is seeking a QA Auditing Reviewer to audit production records, determine batch disposition, and execute those decisions in JDE. You will ensure held or rejected batches are properly stored and you will log RFT data and load batch information into the APR database.

You may fill in for in-process QA inspectors when needed, collaborating with QA teams to maintain GMP compliance and accurate documentation across all manufacturing stages.

Qualifications

• High School diploma or GED required; Bachelor's degree preferred.
• 2+ years in Pharmaceutical QA, QC or QM.
• GMP knowledge; familiarity with 21 CFR Parts 210, 211, 820 and ICH guidance.

Responsibilities

• Audit production records and determine batch disposition (Release, Hold, Reject).
• Physically perform batch disposition in JDE for each lot.
• Ensure batches on Hold/Reject are stored in designated limited-access areas.
• Log RFT data per QA processes; load batch data into APR database if required.
• Communicate clearly, both orally and in writing; operate calculators and PCs.
• Perform timely reviews of QA In-Process Data.

Skills

Calibration

Data Entry

Detail Oriented

Facility Inspection

First Article Inspections

Good Manufacturing Practices

Laboratory Information Management "S"

Quality Management Systems

Visual Inspections

Education

High School or GED

Bachelor's Degree in Related Field

Tools

JDE

APR database

Job description

Amneal Pharmaceuticals is seeking a QA Auditing Reviewer to audit production records, determine batch disposition, and execute those decisions in JDE. You will ensure held or rejected batches are properly stored and you will log RFT data and load batch information into the APR database.

You may fill in for in-process QA inspectors when needed, collaborating with QA teams to maintain GMP compliance and accurate documentation across all manufacturing stages.