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.

OUR GOAL - ONE CELL FOR EVERYONE NO IMMUNE SUPPRESSION. NO DONOR MATCHING. NO REJECTION.

We are a dynamic team of research and scientific professionals who are passionate about turning science and innovation into medical solutions. 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 therapies. Join our team of committed enthusiastic professionals devoted to making the most effective, life-saving cell therapy products in the world.

Universal Cells (UCI) is announcing a Quality Assurance Associate I opportunity at their facility in Seattle, WA .

Purpose:

The primary purpose of the Quality Assurance Associate I is to support the Quality Assurance team in maintaining Standard Operating Procedures, Batch Records, Forms, Templates, Process Support Documentation & Training Materials. This position will have opportunities to train team members and integrate compliance initiatives cross-functionally and identify areas for quality improvements.

Essential Job Responsibilities:

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

  • Maintains 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

  • Participates in 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

Quantitative Dimensions:

  • Direct impact on the company’s Quality Systems

Organizational Context:

  • Reports to Quality Assurance Management

  • Collaborates regularly with Production and R&D teams

Qualifications:

Required:

  • BA/BS degree or equivalent work experience in Quality Assurance.

  • Strong attention to detail and accuracy of work.

  • Ability to explain and interpret information from internal and external sources

  • Ability to think quickly and perform complex tasks

  • Comfort executing routine tasks and generating work instructions to train peers

  • 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:

  • Preferably 1-2 years of related Quality Assurance experience working in a lab environment

  • GMP/GLP 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

Salary Range

  • $56,300 – $75k (NOTE: Final salary could be more or less, based on experience)

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

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Category Quality Assurance

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans

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