Batch Record Review Specialist - 174453

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 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

#LI-BN1

#LI-ONSITE