Batch Record Review Specialist - 174453

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

Benefits offered by this job

Medical

Dental

Vision

401K

PTO

Sick Leave

Job summary

Piper Companies is seeking a Batch Record Review Specialist to review executed batch records and related docs for accuracy, completeness, and cGMP compliance. The role supports timely batch disposition and safe, high-quality biopharmaceutical releases.

Responsibilities include verifying steps against master records and SOPs, identifying discrepancies, and ensuring proper completion of critical parameters. Collaboration with QA, Manufacturing, and Validation is essential.

Qualifications

• 2–5+ years in pharmaceutical or biopharmaceutical manufacturing or QA.
• Strong knowledge of cGMP, GDP, and regulatory requirements.
• Experience reviewing batch records or QA disposition preferred.
• Prior manufacturing experience in upstream/allstream/support services valued.
• Bachelor’s degree in Biology, Chemistry, Pharmaceutical Sciences, or related field.

Responsibilities

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

Skills

Batch record review

GxP compliance

cGMP & GDP

QA disposition

Documentation review

Root cause analysis

Cross-functional collaboration

Education

Bachelor’s degree in Biology/ Chemistry/ Pharmaceutical Sciences

Tools

SAP

Oracle

LIMS

TrackWise

Veeva

MasterControl

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 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

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

This job opens for applications on 8/18/2026. Applications for this job will be accepted for at least 30 days from the posting date

Keywords

Executed Batch Records, EBR, Electronic Batch Record, batch record review, batch record, master batch record, MBR, batch disposition, lot release, right first time, RFT, good documentation practices. GDP, documentation review, record reconciliation, data integrity, SIMPL, ALCOA, ALCOA+, biopharmaceutical manufacturing, aseptic processing, fill-finish operations, fill finish, central service, upstream, downstream, upstream processing, downstream processing, cleanroom operations, line clearance, in-process controls, process validation, tech transfer support, cGMP, GMP compliance, FDA regulations, EMA regulations, quality assurance, QA, quality systems, audit readiness, inspection support, regulatory compliance, SOP adherence, change control, deviations, CAPA, corrective and preventive actions, root cause analysis, non-conformance, NCR, investigation support, exception review, risk assessment, QC data review, certificate of analysis, CoA, analytical testing, environmental monitoring, EM, label reconciliation, logbook review, validation protocols, electronic batch records, EBR systems, MES, PAS-X, ERP, SAP, Oracle, LIMS, TrackWise, Veeva, MasterControl, document management systems, DMS, eDMS, cross-functional collaboration, issue escalation, workflow management, turnaround time optimization, continuous improvement, pharmaceutical, pharma, biopharma, biotech, cleanroom