Job Details

We are seeking a highly motivated and detail-oriented Quality Systems Support Specialist to join our team in Vacaville, CA. This role will provide critical support to the Quality System Management process, focusing on document control and Pharmaceutical Quality System (PQS) integration, while ensuring full compliance with cGMP and global regulatory requirements.

Key Responsibilities

• Support the implementation, execution, and maintenance of PQS integration and Quality Documents within Veeva at the Vacaville site.
• Collaborate with the Quality Document Control group to complete workflows, manage document gating, and coordinate changes to minimize disruption to site operations.
• Manage Quality Documents by:
• Initiating and managing documents in Veeva Quality Docs.
• Formatting and editing controlled documents.
• Tracking and logging requests for source documents.
• Ensure all activities are conducted in compliance with cGMP and global requirements.
• Contribute to maintaining the site in a state of inspection readiness at all times.

Key Requirements

• 1–3 years of experience in Quality within the pharmaceutical or biopharmaceutical industry (supplier quality experience preferred).
• Strong ability to collaborate effectively across diverse, cross-functional teams.
• On-site presence required at the Vacaville, CA location.
• Preferred experience with Veeva Quality Document Management System and Microsoft Teams.
• Technical writing experience strongly preferred.