Batch Records Quality Reviewer I

Amneal Pharmaceuticals LLC (J0P); Piscataway Township (NJ); On-site; USD 24,000 - 32,000; Full time

Job summary

Amneal Pharmaceuticals LLC is seeking a detail-oriented Batch Record Reviewer in New Jersey. The role focuses on accurate timely review of batch records to ensure cGMP compliance, data integrity, and product quality. You will work with Production and QA to support releases and investigations.

Responsibilities include final documentation review, deviation handling, and support during audits. Strong attention to detail and knowledge of SOPs/cGMPs are essential.

Qualifications

• High School or GED required.
• 2+ years in pharma/manufacturing/audit or related experience.
• Strong documentation and data review skills.
• Knowledge of cGMPs and SOPs.

Responsibilities

• Perform final review of manufacturing documentation for completeness and compliance before release.
• Deliver lot status updates to support production and quality activities.
• Ensure deviations, discrepancies, and non-conformances are documented and escalated.
• Document and report identified errors for trend analysis and training.
• Support audits and cross-functional teams during real-time reviews and documentation retrieval.
• Release of production rooms and in-process checks as needed.

Skills

Data review

SOPs knowledge

cGMP knowledge

Documentation

Education

High School diploma or GED

Tools

LIMS

Electronic batch records

Job description

Amneal Pharmaceuticals LLC is seeking a detail-oriented Batch Record Reviewer in New Jersey. The role focuses on accurate timely review of batch records to ensure cGMP compliance, data integrity, and product quality. You will work with Production and QA to support releases and investigations.

Responsibilities include final documentation review, deviation handling, and support during audits. Strong attention to detail and knowledge of SOPs/cGMPs are essential.