| Location | Gaithersburg, MD |
| Salary | $65,000–$85,000 Per Year |
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 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: 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 This job opens for applications on 8/18/2026. Applications for this job will be accepted for at least 30 days from the posting date