Batch Record Reviewer in Newton Center, Massachusetts

Batch Record Reviewer

The Batch Record Reviewer is responsible for the independent review of completed manufacturing batch records to ensure accuracy, completeness, and compliance with cGMP, regulatory requirements, and internal procedures. This role is solely dedicated to batch record review and supports timely lot disposition by identifying and resolving documentation issues prior to Quality Assurance release.

Responsibilities:

• Perform detailed review of completed batch production records for accuracy, completeness, and compliance with approved procedures and cGMP requirements.
• Verify manufacturing documentation, calculations, reconciliations, deviations, and supporting records are complete and acceptable.
• Identify documentation errors, discrepancies, and compliance issues, and coordinate corrections with Manufacturing and Quality personnel.
• Ensure all required quality documentation is complete to support lot disposition decisions.
• Maintain review metrics and support continuous improvement initiatives to enhance documentation quality and review efficiency.
• Adhere to applicable regulatory requirements, company policies, and quality standards.

Qualifications:

• Bachelor's degree in a scientific discipline or equivalent experience.
• 2+ years of experience in Quality Assurance, Manufacturing, or Batch Record Review within a GMP-regulated pharmaceutical, biotechnology, or CDMO environment.
• Strong knowledge of cGMP regulations, GDP, and manufacturing documentation practices.
• Excellent attention to detail, organizational skills, and ability to manage multiple priorities.
• Strong written and verbal communication skills.