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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.

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

  • 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

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

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