Batch Record Review Specialist - Precision & Compliance

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

Benefits offered by this job

Medical, Dental, Vision

401K

PTO

Paid Holidays

Sick Leave

Job summary

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

The specialist will verify steps against master batch records and SOPs, identify deviations, participate in internal audits, and collaborate with Manufacturing, Quality Control, and Validation teams to resolve

Qualifications

• Bachelor’s degree in Biology, Chemistry, Pharmaceutical Sciences, or related field.
• 2–5+ years in pharmaceutical/biopharmaceutical manufacturing or QA.
• Strong knowledge of cGMP, GDP, and regulatory requirements.

Responsibilities

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

Skills

Batch Records Review

cGMP

GDP

Regulatory Compliance

Quality Assurance

QA Disposition

Education

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

Tools

LIMS

Veeva

TrackWise

SAP

Oracle

MasterControl

PAS-X

Job description

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

The specialist will verify steps against master batch records and SOPs, identify deviations, participate in internal audits, and collaborate with Manufacturing, Quality Control, and Validation teams to resolve