Batch Record Review Specialist - 176224

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 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