Astellas Pharma QA Associate II in Seattle, Washington
Universal Cells is focused on the development and commercialization of stem cell and regenerative medicine therapies. We conduct clinical-grade gene editing of stem cells and have a major effort in R&D. We design and produce stem cells that avoid rejection, and we engineer cells with improved therapeutic properties, all through our world-class gene editing platform.
Our goal is to provide cells for regenerative medicine applications that can treat all patients. Through internal R&D and our corporate partnerships, we are pursuing a diverse range of disease indications, including blindness, cancer, vascular insufficiency, and autoimmune diseases.
Universal Cells (UCI) is announcing a QA Associate II opportunity at their facility in Seattle, WA.
The primary purpose of the Quality Systems Associate II 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.
Universal Cells is a wholly-owned subsidiary of Astellas Pharma. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products.
Essential Job Responsibilities:
- Maintains and optimizes Quality Assurance programs including (but not limited to) document control, lot disposition, incident management 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 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
- Leads 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
- A minimum of 3-5 years related Quality Assurance experience in a lab environment
- Expert document editing skills, including a real passion for terminology and an eye for missing details
- Project management skills (including the ability to clearly generate project deliverables, timelines and status updates for project stakeholders)
- Comfort working with peers on Quality Assurance expectations
- Ability to explain and interpret information from internal and external sources
- Ability to think quickly and perform complex tasks
- Ability to write in a technical tone
- Comfort executing routine tasks and generating work instructions to train peers
- Must be detail-oriented and ensure polished documentation
- Cross-functional communication skills and positive attitude with customer service focus
- Strong organizational, time management, and problem solving skills
- Ability to work independently with supervision and ability to effectively collaborate with other teams
- Strong work ethic with a passion for working in a fast-paced, dynamic and diverse work environment
- Bachelor's degree in a technical discipline
- GMP/GLP experience preferred
- Quality Audit experience preferred
- Familiarity with electronic databases (for example: EDMS, SharePoint, Trackwise)
- Experience writing Standard Operating Procedures and Production Batch Records
- Biology or Bio-engineering background related to stem cell culturing, plasmid and rAAV production and product development is preferable
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Quality Assurance/Quality Control