Batch Record Specialist

Job Summary

To support the company's Quality Assurance objectives, the remote Batch Record Specialist will manage the preparation and final release of products by reviewing and verifying batch records, analytical data, and quality control results while ensuring compliance with regulatory standards.

Key responsibilities

• Review and verify executed batch records and analytical data for compliance with SOPs and regulations
• Communicate with CMOs regarding missing documentation and manage records in the electronic Quality Management System (eQMS)
• Write and implement standard operating procedures and support inspection readiness as needed

Required qualifications

• Bachelor's degree in health or life sciences, or relevant experience
• A minimum of 3 years of experience in quality assurance within the pharmaceutical or biotech industry
• Working knowledge of regulatory requirements (FDA, EU) and related standards (GxP, ICH)
• Experience supporting regulatory inspections and interacting with regulatory agencies
• Strong technical and analytical skills with advanced knowledge in MS Office applications