Batch Record Review Specialist - 176507

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 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 escalation 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

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