Batch Record Review (EBR) Specialist

Piper Companies; Gaithersburg (MD); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401K

Paid Time Off

Paid Holidays

Sick Leave

Job summary

Piper Companies is looking for a Batch Record Review Specialist in Gaithersburg, Maryland. The specialist will review executed batch records and documentation to ensure compliance with cGMP and other quality standards. This crucial position supports timely batch disposition and the release of safe biopharmaceutical products.

Candidates should have a Bachelor’s degree in a relevant field and 2–5+ years in pharmaceutical manufacturing or QA. The role offers a competitive salary between $65,000 and $85,000, along with comprehensive benefits like medical, dental, and PTO.

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.

Responsibilities

• Review executed batch records for completeness and accuracy.
• Verify manufacturing steps against approved master batch records.
• Document and escalate discrepancies and deviations.
• Collaborate with Manufacturing, Quality Control, and Validation teams.

Skills

cGMP knowledge

GDP knowledge

Quality Assurance

Batch Record Review

Documentation Practices

Education

Bachelor’s degree in Biology, Chemistry, Pharmaceutical Sciences, or related field

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 escalation 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 of the Batch Record Review Specialist

• 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

Compensation of the Batch Record Review Specialist

• Salary: Between $65,000- $85,000 based on years of relevant experience
• Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO (Paid Time Off), Paid Holidays, Sick Leave as required by law