Batch Record Reviewer

Position Summary

We are seeking a detail-oriented and experienced Batch Record Reviewer to support a six-month on-site project. The selected candidate will be responsible for reviewing manufacturing batch records to ensure compliance with cGMP requirements, internal procedures, and regulatory standards.

Key Responsibilities

• Perform detailed review of batch production records for accuracy, completeness, and compliance with cGMP guidelines
• Verify that all manufacturing steps were executed according to approved procedures and specifications
• Identify discrepancies, errors, or missing information and ensure timely resolution
• Collaborate with Manufacturing, Quality Assurance, and other cross-functional teams to clarify and resolve issues
• Ensure proper documentation practices in accordance with Good Documentation Practices (GDP)
• Support deviation investigations related to batch record discrepancies
• Ensure all documentation is audit-ready and aligned with regulatory expectations (FDA, EMA, etc.)
• Track and manage review timelines to meet production and release schedules
• Participate in continuous improvement initiatives related to documentation and review processes

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field (preferred)
• Minimum of 3+ years of experience in pharmaceutical or biotechnology industry
• Strong experience in batch record review within a cGMP environment
• Knowledge of regulatory requirements (FDA, cGMP, ALCOA+)
• Experience with electronic or paper-based batch records
• Strong attention to detail and organizational skills
• Ability to work independently and in a fast-paced environment

Additional Information

• This is a full-time, on-site role for the duration of the project
• Candidate must be able to work on-site in Indiana
• Immediate availability is preferred