Batch Record Reviewer Group Lead

About the Role

The Batch Record Reviewer Group Lead leads and oversees batch record review activities across manufacturing, packaging, and related operations in a pharmaceutical manufacturing environment. This role ensures timely, accurate, and compliant review of GMP documentation in accordance with regulatory requirements, internal procedures, and quality standards.

Responsibilities

• Lead and perform detailed review of executed batch records (manufacturing, packaging, labeling, and R&D as applicable) for accuracy, completeness, and GMP compliance.
• Review work output for quality, consistency, and adherence to procedures.
• Serve as an escalation point for complex documentation issues or cross-departmental concerns.
• Review and update manufacturing execution systems and/or ERP systems (e.g., JDE or equivalent) to ensure accurate batch status and documentation records.
• Coordinate issuance, control, and reconciliation of batch records, logbooks, labels, and controlled documents.
• Communicate documentation findings, trends, and improvement opportunities to supervisors and management.
• Collaborate with Manufacturing, Packaging, Quality Assurance, Production Planning, and Supply Chain to support work order execution and documentation readiness.
• Identify recurring documentation errors and support corrective and preventive actions (CAPAs).
• Participate in process improvement initiatives to enhance documentation accuracy, efficiency, and compliance.
• Perform other duties as assigned to support quality and operational excellence.

Requirements

• High School diploma or GED (required).
• 2+ years of experience in Manufacturing or Packaging.

Skills

• Strong knowledge of cGMP regulations and pharmaceutical documentation practices.
• Excellent attention to detail and ability to identify documentation errors and trends.
• Effective leadership, coaching, and communication skills.
• Ability to manage multiple priorities and meet timelines in a fast-paced environment.
• Proficiency with ERP/MES systems (e.g., JDE or equivalent) and electronic documentation systems.
• Strong organizational and problem-solving skills.
• Ability to work cross-functionally and communicate clearly at all levels of the organization.

Pay

The hourly rate for this position ranges from $27.00 to $35.00 per hour. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months.

Benefits

• Above-market, diverse, and robust health and insurance benefits.
• Significant 401(k) matching contribution to help employees save for retirement.
• Programs to promote employee well-being, supporting career enjoyment alongside life’s other commitments.