Quality Assurance Specialist

2 weeks ago

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

The Quality Assurance Document Control Associate Specialist supports the cGMP Document Control operations for the Client Cell Therapy Above-site organization, including document approvals, document change control process, periodic review, and system reporting.


Key Responsibilities:

  • Manage an electronic document system for the Cell Therapy Above-Site, reviewing and approving document change requests, troubleshooting, and releasing documents to an effective state.
  • Write and revise document control procedures, 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 if required, assist with document retrieval/organization support during regulatory inspections.
  • Provide communication on the status of Quality Systems deliverables to customers, management, and stakeholders.
  • Some technical writing skills and the ability to critically review documents while effectively inputting and expressing Quality principles.

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 skills, including the ability to critically review documents while effectively inputting and expressing Quality principles.
  • Strong computer skills with MS Office (e.g., Word, Adobe, Visio, and Excel) and with Quality Systems (e.g., Document Management System, Quality Management System).
  • Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement.
  • Able 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.
  • Strong knowledge of cGMPs and domestic regulatory requirements.
  • Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.).
  • Must complete tasks independently, notify manager of decisions outside of established processes, and the ability to build an internal network.

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