Batch Record Quality Assurance Specialist

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 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.