Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch's global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world's leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures for the world's deadliest diseases and make life beyond cancer a reality.

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.

The Cellular Therapeutics Quality Department 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 creating, developing, and monitoring and managing of quality systems that support cellular collection, processing and infusion for the Apheresis Unit and Cellular Therapy Laboratory. A person in this position works on complex problems with analysis of situations or data requires an in-depth evaluation of various factors and exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. Tasks are typically carried out with no instruction on routine work and may provide guidance to other lower personnel.

Responsibilities

• Participate in development and implementation of quality systems to assure compliance with relevant standards and regulations; specifically, but not limited to cGTP, cGMP and FACT.
• Identify deviations or potential sources of deviations during product processing records review and product release. Work with Operational management to ensure timely submission of deviations.
• Review, evaluate and investigate deviations; coordinate corrective actions with Operational staff. Work with Operational management to properly close variances.
• Perform investigations on issues related to product quality. Perform root cause analysis, identify issue(s) and potential corrective and preventive actions.
• Review product processing records to ensure compliance with standard operating procedures and release criteria. Ensure processing adheres to Sponsor specific requirements for clinical trials/commercial products as outlined on protocol/product specific batch records. This includes performing read offs with Operational staff and resolving issues during the release process.
• Provide QA support in developing and executing new or nonstandard procedures and processes as needed.
• Assist QA Management or Specialists to train staff on Quality systems.
• Work with the Quality Assurance Specialist to identify and develop quality indicators based on improvement efforts and quality led projects.
• Author, review and qualify controlled documents such as standard operating procedures (SOP's) to achieve compliance with regulatory and accreditation requirements.
• Perform in-process improvement projects as a Quality Subject Matter Expert. Able to recommend changes to controlled documents as necessary.
• Familiarity with CTP Quality Systems/functions such as, but not limited to, CAPA/EC, supplier/vendor qualification, cellular therapy product manufacture qualification, change control, engraftment data management including delayed/failed engraftment investigation, and serious adverse reaction investigation.

Qualifications

Required:

• B.S. degree with a major in biological science, medical technology or related discipline; or equivalent combination of experience and education.
• 2-4 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 and competent with MS Office programs
• Excellent interpersonal skills
• Proven ability to multi-task and strong attention to details and accuracy

Preferred:

• Working knowledge of FACT standards
• Experience with batch record review/approval, performing investigations, performing audits preferred
• Previous experience with Laboratory Information Systems and Part 11 compliance desired
• Previous project management or project oversight experience desired

SCCA has a mandatory COVID-19 vaccination policy, and there are no exceptions for any employee who is patient-facing and/or requires access to SCCA facilities.

Exceptions exist only for employees whose positions are fully remote, with no required access to campus. As a condition of employment, newly hired employees requiring access to campus must provide proof of vaccination before their first day of employment.

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Our Commitment to Diversity

We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, 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 hrops@fredhutch.org or by calling 206-667-4700.