Batch Record Review (EBR) Specialist

About the Role

This position is critical to supporting timely batch disposition and ensuring the release of safe, high-quality biopharmaceutical products. The Batch Record Review Specialist will review executed batch records and related manufacturing documentation to ensure accuracy, completeness, and compliance with cGMP, regulatory requirements, and internal quality standards.

Responsibilities

• Review executed batch records (EBRs) for completeness, accuracy, and adherence to GDP (Good Documentation Practices).
• Verify manufacturing, packaging, and testing steps against approved master batch records and SOPs.
• Identify, document, and escalate discrepancies, deviations, and non-conformances.
• Ensure all critical process parameters, in-process controls, and documentation are properly completed.
• Review supporting documentation, including logbooks, labels, and QC data.
• Collaborate with Manufacturing, Quality Control, and Validation teams to resolve issues impacting batch release.
• Support batch disposition activities, ensuring timely and compliant product release.
• Review deviations, investigations, and CAPAs for completeness and impact on product quality.
• Participate in internal audits, inspections, and continuous improvement initiatives.

Requirements

• 2–5+ years of experience in pharmaceutical or biopharmaceutical manufacturing or quality assurance.
• Strong knowledge of cGMP, GDP, and regulatory requirements.
• Experience reviewing batch records, manufacturing documentation, or QA disposition preferred.
• Prior experience working in manufacturing (upstream/allstream/support services) would be a plus.
• Bachelor’s degree in Biology, Chemistry, Pharmaceutical Sciences, or related field.

Pay

Salary: Between $65,000–$85,000 based on years of relevant experience.

Benefits

• Medical, Dental, and Vision coverage.
• 401K retirement plan.
• Paid Time Off (PTO).
• Paid Holidays.
• Sick Leave as required by law.