Batch Record Review (EBR) Specialist

Piper Companies
📍 Gaithersburg, Maryland, United States 💼 Full-time 🕒 Posted July 02, 2026

Job Description

Piper Companies is seeking a Batch Record Review Specialist who will be responsible for reviewing executed batch records and related manufacturing documentation to ensure accuracy, completeness, and compliance with cGMP, regulatory requirements, and internal quality standards. This role is critical to supporting timely batch disposition and ensuring the release of safe, high-quality biopharmaceutical products.

Responsibilities of the Batch Record Review Specialist:

·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...

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Job Details

  • Location Gaithersburg, Maryland
  • Job Type Full-time
  • Category Life, Physical, and Social Science Technicians
  • Posted Date July 02, 2026
  • Application Deadline August 11, 2026