Job Details

The Technical Specialist, Quality Assurance Document Control, reporting to the Head of QA Document Control Novato, is responsible for supporting the management of all aspects related to documentation control processes for Quality Assurance and Quality Control and the management of documents in the Veeva Quality Management System. This role requires a working knowledge of Good Manufacturing Practices (GMP), FDA/ EMA regulations and will involve collaboration with cross-functional teams to maintain BioMarins commitment to quality and compliance. KEY RESPONSIBILITIES - Support the development, implementation, maintenance and improvement of the document control system in accordance with FDA, EMA, and other regulatory agency requirements, ensuring that all quality documents are properly and efficiently managed and accessible. - Support the maintenance of QADC hours for Logbooks, corrections, and archive access during business hours with additional hours as needed during audits and inspecti...QA, Operations Specialist, Operations, Quality Assurance, Specialist, Support, Technology