The Seattle Cancer Care Alliance (SCCA), 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.
The Cellular Therapeutics (CTP) Quality Department is responsible for all therapeutic cellular collection and processing occurring at the Seattle Cancer Care Alliance (SCCA). All products collected, manufactured and distributed 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.
Under the direction of CTP Quality Assurance management, contributes to and supports the Quality department in efforts related to compliance and daily operations of the Quality Department.
This individual works in a collaborative fashion within CTP and across the organization to ensure product safety and regulatory requirements.
The regular schedule for this position will be M-F 10am-6:30pm.
Review, evaluate and investigate deviations; coordinate corrective actions with Operational staff. Work with Operational management to properly close variances.
Review product processing records to ensure compliance with standard operating procedures and release criteria.
Author, revise and review controlled documents. Able to recommend changes to documents as necessary.
Help monitor the quality of purchased materials and equipment used in manufacturing.
Perform review of product removal process for CTL.
Assist in the tracking and trending of quality indicators.
Assist with Document Control activities.
Maintain Quality Systems as needed.
Perform other assignments 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
Able to communicate ideas effectively both verbally and in writing and to facilitate change
Able to interact constructively with peers, management and outside contact
Experience with batch record review/approval, performing investigations, performing audits
Experience with computer databases including statistical software
Previous experience with Laboratory Information Systems and Part 11 compliance
Previous project management or project oversight experience
Consistently interacts constructively with peers, management and outside contacts
We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at email@example.com or by calling 206-667-4700.
The Seattle Cancer Care Alliance was incorporated in 1998 as a separate, jointly governed non-profit that included the cancer programs of three partners. Seattle Cancer Care Alliance is a cancer treatment center that unites doctors from Fred Hutchison Cancer Research Center, University of Washington Medical Center, and Seattle Children’s. The purpose of this organization is to provide state-of the-art patient and family centered care; support the conduct of cancer clinical research and education; enhance access to improved cancer interventions; and advance the standard of cancer care regionally and beyond. The Seattle Cancer Care Alliance is the only NCI-designated comprehensive cancer center in the Northwest, and according to the National Cancer Data Base, Seattle Cancer Care Alliance patients in general have better survival rates than patients treated at other cancer treatment centers.