QA Documentation Specialist I Job at eTeam, Vacaville, CA

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  • eTeam
  • Vacaville, CA

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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