Document Control Specialist

2 weeks ago

Seattle, Washington, United States Omni Inclusive Full time

Job Description:

The Omni Inclusive team is seeking a highly skilled Document Control Specialist to support the cGMP Document Control operations for our Cell Therapy organization. This role involves managing an electronic document system, reviewing and approving document change requests, and troubleshooting documents to ensure they are in an effective state.

Responsibilities:

  • Manage an electronic document system for the Cell Therapy Above-Site, including reviewing and approving document change requests.
  • Troubleshoot and release 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 train workflows.
  • 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 as required.
  • Provide communication regarding the status of Quality Systems deliverables to customers, management, and stakeholders.

Requirements:

  • Minimum 1 year of relevant document control experience in a cGMP/FDA regulated environment.
  • Strong communication and customer service skills.
  • Technical writing skill set, including critically reviewing documents while effectively inputting and expressing Quality principles.
  • Strong computer skills with MS Office (e.g. Word, Adobe, Visio, and Excel) and Quality Systems (e.g. Document Management System, Quality Management System).
  • Able to prioritize, manage time well, multitask, and troubleshoot effectively.

Salary: The estimated salary for this position is $65,000 - $85,000 per annum, based on industry standards and location.

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