Quality Assurance Associate I / Associate II
Astellas


Job Info


Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. 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.



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 Systems 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


Benefits:


* Medical, Dental and Vision Insurance
* Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
* 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



Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans



#LI-JA1

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled



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