Batch Record Reviewer Group Lead
Amneal Pharmaceuticals
August 24, 2026
Remote friendly (Piscataway, NJ)
United States
Operations
The Batch Record Reviewer Group Lead is responsible for leading and overseeing batch record review activities across manufacturing, packaging, and related operations in a pharmaceutical manufacturing environment, ensuring timely, accurate, and compliant review of GMP documentation.
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/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 CAPAs.
- Participate in process improvement initiatives to enhance documentation accuracy, efficiency, and compliance.
Qualifications:
- Education: High School or GED (Required)
- Experience: 2+ years in Manufacturing or Packaging
Skills/Knowledge:
- Strong knowledge of cGMP regulations and pharmaceutical documentation practices
- Excellent attention to detail; ability to identify documentation errors and trends
- 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
Pay/Benefits (as stated): Hourly rate $27.00–$35.00; short-term incentive opportunity within first 12 months.
Additional: Perform other duties as assigned to support quality and operational excellence.
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/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 CAPAs.
- Participate in process improvement initiatives to enhance documentation accuracy, efficiency, and compliance.
Qualifications:
- Education: High School or GED (Required)
- Experience: 2+ years in Manufacturing or Packaging
Skills/Knowledge:
- Strong knowledge of cGMP regulations and pharmaceutical documentation practices
- Excellent attention to detail; ability to identify documentation errors and trends
- 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
Pay/Benefits (as stated): Hourly rate $27.00–$35.00; short-term incentive opportunity within first 12 months.
Additional: Perform other duties as assigned to support quality and operational excellence.