Specialist, Quality Assurance, Universal Cells

Are you a highly motivated, collaborative, and scientifically curious individual? If so, we're seeking you, and your bold ideas, to co-lead and accelerate the development of our research programs for patients in need. Here, at Astellas, we are a driven bunch with a passion for testing the capabilities of iPSC-derived cells and for developing them into transformational therapies. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

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. 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 indications.

OUR GOAL - ONE CELL FOR EVERYONE

NO IMMUNE SUPPRESSION. NO DONOR MATCHING. NO REJECTION.

Universal Cells (UCI) is announcing a Specialist, Quality Assurance, Universal Cells, opportunity at our facility in Seattle, WA.

Purpose and Scope:

The primary purpose of this position is to develop, author, review and approve Standard Operating Procedures, Batch Records, Forms, Templates, Process Support Documentation & Training Materials. This position will have opportunities to integrate compliance initiatives cross-functionally, provide ownership for internal processes and identify areas for quality improvements.

Essential Job Responsibilities:

• Maintains and optimizes Quality Assurance programs including (but not limited to) document control, lot disposition, deviation and material management.


• Authors Standard Operating Procedures, Batch Records, Forms/Templates, Process Support Documentation & Training Materials.


• Edits documentation for clarity, consistency, organization, and effectiveness.


• Performs reviews of Executed Logbooks, Batch Records, and other documentation.


• Works directly with Subject Matter Experts to develop content or provide meaningful feedback to improve structure and flow of documentation.


• Develops and delivers training materials, generates document solutions for optimization and risk mitigation, creates improved communication mechanisms.


• Performs other duties as assigned or special projects as needed.