Batch Record Review & Quality Compliance Specialist

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

Benefits offered by this job

Medical

Dental

Vision

401K

PTO

Holidays

Sick Leave

Job summary

Piper Companies is seeking a Batch Record Review Specialist to ensure batch records and related documentation meet cGMP, GDP, and regulatory standards for timely release of biopharmaceutical products.

The role emphasizes collaboration with Manufacturing, QC and Validation teams to resolve issues, review deviations, and support continuous improvement in a fast-paced biopharma environment.

Qualifications

• 2–5+ years in pharma/biopharma manufacturing or QA.
• Solid knowledge of cGMP and GDP and regulatory requirements.
• Experience reviewing batch records, manufacturing documentation or QA disposition.
• Experience in manufacturing operations is a plus.

Responsibilities

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

Skills

cGMP knowledge

GDP knowledge

QA disposition

Documentation review

Cross-functional collab

Education

BS in Life Sciences

Tools

LIMS

TrackWise

Veeva

MasterControl

Job description

Piper Companies is seeking a Batch Record Review Specialist to ensure batch records and related documentation meet cGMP, GDP, and regulatory standards for timely release of biopharmaceutical products.

The role emphasizes collaboration with Manufacturing, QC and Validation teams to resolve issues, review deviations, and support continuous improvement in a fast-paced biopharma environment.