Specialist, Quality Assurance - Astellas Pharma

**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. **Qualifications Required:** + Bachelor's degree in a technical discipline, with at least 3 years of related Quality Assurance experience. + Ability to write in a technical tone and train staff. + Cross-functional communication skills and positive attitude with customer service focus. + GMP/GLP experience. **Preferred:** + Familiarity with electronic databases (for example: EDMS, SharePoint, Trackwise) and strong computer skills with Word and Excel. + Experience authoring/revising Standard Operating Procedures. + Hands-on experience with batch record review and product disposition is preferred. + Biology or Bio-engineering background related to stem cell culturing, plasmid and rAAV production and product development. **Working Environment:** + This position is based in Seattle Washington and will require on-site work. **Benefits:** + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Referral bonus program \#LI-TD Category BioPharma QA Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans