QA Specialist (Batch Record Reviewer)

Role: QA Specialist responsible for reviewing and releasing semi-finished and finished drug products, ensuring GMP compliance and adherence to SOPs. Responsibilities: perform batch record reviews, monitor products on hold, prepare batch disposition documentation for international sites, and ensure regulatory compliance. Manage product quarantine, identify and resolve discrepancies, and finalize product release in SAP with independent judgment. Qualifications: Bachelor's in Sciences or technical field, 5+ years in quality roles handling documentation; GMP experience (minimum 3 years), intermediate skills in Microsoft Word and Excel, SAP experience preferred. Additional skills include familiarity with QA systems, cGMPs, ISO regulations, and electronic quality systems like Maximo and Trackwise. High-Value: biologics or aseptic manufacturing environment experience; focus on drug product release within a GMP setting; global regulatory compliance. Collaboration: support manufacturing, validation, and quality assurance departments, with international documentation responsibilities. WorkSetup: not specified; travel requirements not mentioned.