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Quality Assurance Document Specialist

1 week ago


Bothell, Washington, United States Omni Inclusive Full time

Omni Inclusive is seeking a skilled Quality Assurance Document Specialist to support the cGMP Document Control operations for our Bothell site. The successful candidate will be responsible for managing an electronic document system, reviewing and approving document change requests, and troubleshooting documents to ensure they are in an effective state.

The ideal candidate will have experience with EDMS systems, strong communication and customer service skills, and the ability to work effectively and collaboratively at a fast pace with cross-functional departments. Additionally, the candidate should possess project management skills and be able to prioritize, manage time well, multitask, and troubleshoot effectively.

Key responsibilities include:

  • Managing an electronic document system for the Bothell site
  • Reviewing and approving document change requests
  • Troubleshooting and releasing documents to an effective state
  • Assisting with cross-training of Document Control personnel and customers
  • Executing the process and procedures for identifying, collecting, distributing, and filing controlled documents for the site

In addition to these responsibilities, the Quality Assurance Document Specialist will also support internal and external audits and regulatory inspections if required.