Batch Record Review Specialist

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 supports timely batch disposition and the release of safe, high‑quality biopharmaceutical products.

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 escalate 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

• 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/all‑stream/support services) is a plus.
• Bachelor’s degree in Biology, Chemistry, Pharmaceutical Sciences, or a related field.

Compensation

Salary: $65,000 – $85,000, based on years of relevant experience.

Benefits

• Medical
• Dental
• Vision
• 401(k) retirement plan
• PTO (Paid Time Off)
• Paid holidays
• Sick leave as required by law

Applications open on 8/18/2026 and will be accepted for at least 30 days from the posting date.