Batch Record Reviewer I: Data Integrity & Compliance

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

Job summary

Amneal Pharmaceuticals LLC is seeking a Batch Record Reviewer I to ensure accurate and timely review of batch records in support of product release and patient safety.

The role requires 2+ years in pharmaceutical manufacturing or related fields, with strong knowledge of SOPs and cGMPs, and a high school diploma or GED. The position offers on-site work in New Jersey and a comprehensive benefits program.

Qualifications

• High School or GED required.
• 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.
• Flexibility to adapt to changing job requirements.
• Clear and professional communicator.

Responsibilities

• Perform final review of manufacturing documentation for completeness and compliance with cGMP, SOPs, and regulatory requirements before release.
• Deliver requested lot status updates to support production and quality activities.
• Ensure deviations, discrepancies, and non-conformances are properly documented and escalated for investigation.
• Document and report identified documentation errors to management, ensuring proper tracking for trend analysis and training/continuous improvement.
• Support QA–Manufacturing, Compliance, and Investigation groups during real-time reviews and provide record retrieval and filing across departments.
• Provide support during internal/external audits as requested.
• Release of production rooms and in-process checks; review/audit of E-log books.
• Entry of engineering work orders and coordination of preventive maintenance.

Skills

SOPs & cGMPs knowledge

Education

High School or GED

Job description

Amneal Pharmaceuticals LLC is seeking a Batch Record Reviewer I to ensure accurate and timely review of batch records in support of product release and patient safety.

The role requires 2+ years in pharmaceutical manufacturing or related fields, with strong knowledge of SOPs and cGMPs, and a high school diploma or GED. The position offers on-site work in New Jersey and a comprehensive benefits program.