Quality Batch Records Reviewer I

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

Benefits offered by this job

Health benefits

401(k) matching

Incentives (bonus/RSU)

Job summary

Amneal Pharmaceuticals LLC is seeking a Batch Records Reviewer to ensure accurate and timely review of manufacturing documentation for cGMP compliance and regulatory standards. You will verify data entries, calculations, and documentation, resolving discrepancies to support product release.

Collaborating with Production and QA, you will help maintain data integrity, support audits, and contribute to continuous improvement through proper trending and training documentation.

Qualifications

• 2+ years in Pharmaceutical, manufacturing, auditing or related experience.
• Competent knowledge of SOPs, cGMPs and mechanical aptitude.
• Ability to identify issues and develop practical solutions.
• Flexible to adapt to changing job requirements.
• Clear and professional communicator.

Responsibilities

• Perform final review of manufacturing documentation for completeness and compliance before release.
• Provide lot status updates to support production and quality activities.
• Document and escalate deviations, discrepancies and non-conformances for investigation.
• Report identified documentation errors to management and support trend analysis and training.
• Support QA-Manufacturing, Compliance and Investigation groups during real-time reviews and assist with record retrieval across departments.
• Assist during internal/external audits as requested.

Skills

Attention to detail

SOPs knowledge

cGMPs knowledge

Communication skills

Problem solving

Education

High School or GED

Job description

Amneal Pharmaceuticals LLC is seeking a Batch Records Reviewer to ensure accurate and timely review of manufacturing documentation for cGMP compliance and regulatory standards. You will verify data entries, calculations, and documentation, resolving discrepancies to support product release.

Collaborating with Production and QA, you will help maintain data integrity, support audits, and contribute to continuous improvement through proper trending and training documentation.