Quality Assurance Associate II @ Fred Hutchinson Cancer Research Center
The Seattle Cancer Care Alliance, located in Seattle, Washington, is part of a dynamic collaboration among three organizations known nationally and internationally for their patient care and research: Fred Hutchinson Cancer Research Center, University of Washington, and Seattle Children's.
Over the past 25 years, these institutions have worked together to support their mission of adult and pediatric oncology patient care services, research and education. Join us and make a difference!
About the Department
The Controlled Cellular Production group is responsible for all therapeutic cellular collection and processing occurring at the Seattle Cancer Care Alliance (SCCA). All products manufactured by the Apheresis Unit or Cellular Therapy Laboratory must meet or exceed required Food and Drug Administration (FDA) regulations for potential use in human clinical studies, as well as compliance with the Foundation for the Accreditation of Cellular Therapy (FACT) standards, and other applicable governing agency regulations.
The Quality Assurance Associate II is responsible for developing and monitoring quality systems that support cellular collection, processing and infusion for the Controlled Cellular Production’s Apheresis Unit and Cellular Therapy Laboratory. A person in this position works on problems with diverse scope in which analysis of data requires evaluation of identifiable factors and exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Tasks are typically carried out with no instruction on routine work and general instruction on new assignments.
• Assist in the development and implementation of quality systems in compliance with relevant standards and regulations.
• Work with Quality Improvement Specialist and Data Coordinator to identify and develop quality indicators based on improvement efforts and quality led projects. Assist in the tracking and trending of quality indicators.
• Participate in internal audits of quality systems.
• Develop, write and review equipment and process validation protocols.
• Review, evaluate and investigate deviations; coordinate corrective actions with Operational staff. Work with Operational staff on completion of identified CAPA. Work with Operational Management to properly close variances.
• Participate in process improvement projects as a Quality Subject Matter Expert.
• Oversee the environmental monitoring program; includes performance of, and trending of data
• Work collaboratively with Operational staff, Process Development Specialists and Quality Operation Specialists on controlled documents, including SOPs, Investigations, and CAPAs.
• Help maintain Quality Systems on behalf of CCP Quality (i.e., variance management system, Vendor Qualification, Change Control, etc).
• Prepares correspondence, memos, and letters in proper format and with a professional appearance.
• Other duties as assigned.
• B.S. degree with a major in biological science, medical technology or related discipline.
• 2-5 years of cellular or biological manufacturing experience including quality assurance responsibilities. Working knowledge of cGMP/cGTP regulations is required.
• Able to communicate ideas effectively both verbally and in writing and to facilitate change. Able to interact constructively with peers, management and outside contacts.
• Experience with computer databases including statistical software preferred.
• Previous experience with evaluation and/or implementation of Laboratory Information Systems and Part 11 compliance desired
• Previous project management or project oversight experience desired
Pay,Benefits, & Work Schedule
Salary DOE+ excellent benefits
How To Apply
To apply for this position please click on the "Apply Now" button below. If you have not previously registered with us you will be prompted to do so; otherwise, please follow the online directions to submit your resume and/or cover letter.
Equal Employment Opportunity
The Fred Hutchinson Cancer Research Center and The Seattle Cancer Care Alliance are equal opportunity employers, committed to workforce diversity.
Closing date: Contact employer