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Quality Assurance Document Control Specialist

2 months ago

Seattle, Washington, United States Omni Inclusive Full time
Job Summary

We are seeking a highly skilled Quality Assurance Document Control Specialist to join our team at Omni Inclusive. The successful candidate will be responsible for supporting the cGMP Document Control operations for our Cell Therapy Above-site organization.

Key Responsibilities
  • Manage an electronic document system, reviewing and approving document change requests, troubleshooting, and releasing documents to an effective state.
  • Write and revise document control procedures, including participating in the development and roll-out of document control tools.
  • Follow policies, SOPs, and work instructions to support the document approval process, assign effective dates, and training workflows, and archive documents and document change requests.
  • Assist with cross-training of Document Control personnel and customers to ensure adherence with procedures.
  • Execute the process and procedures for identifying, collecting, distributing, and filing controlled documents for the site.
  • Generate document management system reports for Quality Council metric reporting.
  • Support internal and external audits and regulatory inspections, and assist with document retrieval/organization support during regulatory inspections.
  • Provide communication on the status of Quality Systems deliverables to customers, management, and stakeholders.
Requirements
  • Minimum of 1 year of relevant document control experience in a cGMP/FDA regulated environment.
  • Strong communication and customer service skills.
  • Some technical writing skill set, including the ability to critically review documents while effectively inputting and expressing Quality principles.
  • Strong computer skills with MS Office and Quality Systems.
  • Ability to prioritize, manage time well, multi-task, and troubleshoot effectively.
  • Ability to work effectively and collaboratively at a fast pace with cross-functional departments to finalize time-sensitive deliverables.
  • Possess project management skills.
  • Experience interacting with FDA or other regulatory agencies strongly preferred.