Technical Specialist, Quality Assurance Document Control

Job Description

SUMMARY

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 BioMarin's 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 inspections.
• Ensure all quality documents are properly managed, accessible, and adhere to Good Documentation Practices (GDP).
• Support the management of the lifecycle of quality documents, including archiving and retrieval processes.
• Support the maintenance of multiple databases such as Logbook trackers, scanned logbooks, notebook trackers, and offsite storage.
• Support the management of the backlog of documents in the Veeva system, ensuring periodic review and timely lifecycle management of documents, including Documents to Effective (DtE) and Documents to Approval (DtA).
• Collaborate with cross-functional teams to ensure alignment on documentation practices and support quality initiatives.
• Ensure right the first time and compliance in all QA Document Control Activities.
• Ensure documents are returned promptly and maintain efficient flow of physical documents.
• Ensure audit readiness of QADC areas and act as a key point of contact for audits and inspections.
• Support the archival of documentation and ensure the QA Document Control room is always audit- ready.
• Support training team members as needed.
• Other duties as assigned.

Experience :

Education :

Other :

Equal Opportunity Employer : We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

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