Job Description
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.
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