Batch Record QA Specialist — cGMP & Compliance

ZP Group; Gaithersburg (MD); On-site; USD 65,000 - 85,000; Full time

Job summary

Piper Companies is seeking a Batch Record Review Specialist to review executed batch records and related manufacturing documentation for accuracy, completeness, and compliance with cGMP and regulatory standards. This role supports timely batch disposition and the release of safe, high‑quality biopharmaceutical products.

Responsibilities include verifying records against master batch records, identifying discrepancies, and collaborating with Manufacturing, QC, and Validation to resolve issues

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.

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 elevate 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

Skills

cGMP knowledge

GDP knowledge

Regulatory compliance

Batch records review

Education

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

Tools

SOP adherence

QA documentation systems

Job description

Piper Companies is seeking a Batch Record Review Specialist to review executed batch records and related manufacturing documentation for accuracy, completeness, and compliance with cGMP and regulatory standards. This role supports timely batch disposition and the release of safe, high‑quality biopharmaceutical products.

Responsibilities include verifying records against master batch records, identifying discrepancies, and collaborating with Manufacturing, QC, and Validation to resolve issues