Batch Record Review Specialist - 174453

About the role

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

• 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

Qualifications

• 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
• Vision
• 401K
• PTO (Paid Time Off)
• Paid Holidays
• Sick Leave as required by law