Biopharma Batch Records QA Reviewer

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

Benefits offered by this job

Comprehensive benefits

Job summary

Piper Companies seeks a Batch Record Review Specialist to ensure EBRs and related docs meet cGMP, GDP, and regulatory standards. You will support timely batch disposition and safe, high-quality product release.

Responsibilities include verifying records against master batch records and SOPs, identifying discrepancies, and collaborating with Manufacturing, QC, and Validation teams to resolve issues affecting release.

Qualifications

• Bachelor’s degree in Biology, Chemistry, Pharmaceutical Sciences, or related field.
• 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 is preferred.

Responsibilities

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

Skills

Experience 2-5 yrs

cGMP knowledge

GDP knowledge

QA disposition experience

Education

Bachelor’s degree (Biology/Chemistry/Pharma)

Tools

SAP

LIMS

TrackWise

Veeva

MasterControl

Oracle

Job description

Piper Companies seeks a Batch Record Review Specialist to ensure EBRs and related docs meet cGMP, GDP, and regulatory standards. You will support timely batch disposition and safe, high-quality product release.

Responsibilities include verifying records against master batch records and SOPs, identifying discrepancies, and collaborating with Manufacturing, QC, and Validation teams to resolve issues affecting release.