Quality - (CW) QA Operations Specialist (TEMPORARY)

Role 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.

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.

Qualifications

• Minimum of 3 years within the biotechnology or pharmaceutical industry.
• Extensive knowledge of GMP, FDA, EMA, and other regulatory requirements.
• Proficient in Veeva EDMS.

Education

• BA/BS in life sciences or related field
• Advance degree desirable but not required.

Additional Requirements

• This role is hybrid and requires employee to be onsite three days/week. Onsite hours could be increased during FDA audits, Internal Audits or other special occasions.