Quality Assurance Associate I
Astellas

Universal Cells, an affiliate of Astellas located in Seattle, WA, is focused on the development and commercialization of stem cell and regenerative medicine therapies. We conduct clinical-grade gene editing of stem cells to produce cells that avoid rejection and can be used in allogeneic cell therapy treatments to treat all patients that need them.

OUR GOAL - ONE CELL FOR EVERYONE NO IMMUNE SUPPRESSION. NO DONOR MATCHING. NO REJECTION.

We are a dynamic team of research and scientific professionals who are passionate about turning science and innovation into medical solutions. Through our diversity, scientific knowledge, professional rigor and focus on innovation, we are merging our technology with the Astellas drug development expertise to unlock cures to many therapies. Join our team of committed enthusiastic professionals devoted to making the most effective, life-saving cell therapy products in the world.

Universal Cells (UCI) is announcing a Quality Assurance Associate I opportunity at their facility in Seattle, WA.

Purpose:

The primary purpose of the Quality Assurance Associate I is to support the Quality Assurance team in maintaining Standard Operating Procedures, Batch Records, Forms, Templates, Process Support Documentation & Training Materials. This position will have opportunities to train team members and integrate compliance initiatives cross-functionally and identify areas for quality improvements.

Essential Job Responsibilities:

• Maintains and optimizes Quality Assurance programs including (but not limited to) document control, lot disposition, incident management and material management.
• Maintains Standard Operating Procedures, Batch Records, Forms/Templates, Process Support Documentation & Training Materials
• Edits documentation for clarity, consistency, organization, and effectiveness
• Performs Executed Logbook and Executed Batch Record reviews
• Works directly with Subject Matter Experts to develop content or provide meaningful feedback to improve structure and flow of documentation
• Participates in customer meetings and identifies required potential changes to documentation, takes meeting minutes and communicates status to cross-functional audiences
• Develops training materials, generates document solutions for optimization and risk mitigation, creates improved communication mechanisms
• Performs other duties as assigned or special projects as needed

Quantitative Dimensions:

• Direct impact on the company's Quality Systems

Organizational Context:

• Reports to Quality Assurance Management
• Collaborates regularly with Production and R&D teams

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