Astellas Veterans Jobs

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.

Purpose:

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

Qualifications:

Required

• Experience:

• For QA Associate I: 0-3 years related Quality Assurance experience in a lab environment

• For QA Associate II: 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

Preferred

• 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

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Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Category Quality Assurance/Quality Control