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 to the world's deadliest diseases and make life beyond cancer a reality.
The Clinical Technologist II - Certified (Quality) is an integral member of both the Clinical Laboratory Team and the Cellular Therapeutics Quality Team with two primary roles: Supporting management of the SCCA POCT Program and supporting Cellular Therapeutics compliance to FDA and accreditation body standards.
The Quality Technologist (QT) will be responsible for POCT and associated Quality Processes under the direction of the QA Manager, Clinical Labs. The program provides oversight of all testing performed at the points of patient care throughout the SCCA Clinic. The program is overseen and run by the Lab Quality Department. Testing includes all testing completed at the bed side during patient care. Testing personnel include nurses, physicians, MAs and other clinical care providers.
The Cellular Therapeutics (CTP) Quality Department is responsible for all therapeutic cellular collection and processing occurring at the Seattle Cancer Care Alliance (SCCA). Under the direction of the CTP Quality Regulatory Compliance Manager, the QT will be responsible for ensuring cellular product safety and regulatory compliance within Cellular Therapeutics.
Clinical Laboratory Quality
Support laboratory quality improvement meetings and special projects as designated and maintains the Lab Quality Dashboard
Performs Document Control Procedures for Clinical Laboratories as needed
May review documents for compliance and appropriateness that are generated by the laboratories such as validations and Standard Operating
Perform other duties as assigned
Handles biological specimens and products; performs clinical assays and lab processes by following the Standard Operating Procedures
Performs regular maintenance and troubleshooting on analytical instruments
Audits accuracy and reporting of results
Participates in orientation, training, and competency assessments for all POCT Staff
Responsible for coordinating inventory needs with materials management
Develops and validates POCT related equipment and processes
Is responsible for quality control processes and data
Performs advanced processes maintenance and troubleshooting
Perform other duties as assigned
Cellular Therapeutics Quality
Review product processing records to ensure compliance with standard operating procedures and release criteria. This includes performing read offs with Operational staff and resolving issues during the release process.
Learn and be able to perform all Document Control responsibilities and act as back-up to the Document Control Specialist as needed
Review, evaluate and investigate deviations. Work with Operational management to properly close variances. Coordinate corrective actions with Operational staff.
Work with Operational management or QA Specialists to train staff on Quality systems
Author, revise, review and qualify standard operating procedures (SOPs) as needed
Perform in-process improvement projects as a Quality Subject Matter Expert. Able to recommend changes to controlled documents as necessary
Contributes to the development and implementation of Quality systems in compliance with relevant standards and regulations
Work with the Quality Specialists to identify and develop Quality indicators based on improvement efforts and Quality led projects
Familiarity with CTP Quality Systems (e.g. deviation management system, vendor qualification, change control, audits, metrics etc.)
Perform other duties as assigned
Education and Certification:
A Bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution OR An associate degree in a laboratory science or medical laboratory technology from an accredited institution or equivalent education and training that includes 24 semester hours of medical laboratory technology courses or 24 semester hours of science courses that include six semester hours of chemistry, six semester hours of biology and twelve semester hours of chemistry, biology, or medical laboratory technology in any combination AND have laboratory training that includes completion of a clinical laboratory training program approved or accredited by an HHS-approved organization, or at least 3 months documented laboratory training is each specialty in which the individual performs high complexity testing.
Medical Laboratory Scientist, Medical Technologist or an equivalent certification with certified maintenance of continuing education through ASCP, AMT or AAB.
Minimum of 2 years of clinical lab or research experience required
Ability to interpret applicable regulations (FDA/FACT/CAP/CLIA/DOH/ASHI)
Shares learned information Performs laboratory quality controls measurements
Ability to organize and manage time and tasks independently
Proficiency with email, spreadsheets, and word processing
Manual computation skills
Ability to communicate verbally in person, on the phone, and in writing in a clear, concise and professional manner
Attention to detail
Ability to work in a high pressure, time-sensitive, and complex health care environment
Ability to identify and triage issues appropriately
Familiarity with medical terminology
Knowledge and understanding of applicable laboratory regulations preferred
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.
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 HR Operations at HRops@fredhutch.org or by calling 206-667-4700.
At Fred Hutchinson Cancer Research Center, teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Researchers are discovering new ways to detect cancers earlier, improve treatments, and learn how to prevent cancers from growing. Although Fred Hutchinson opened its doors in 1975, its history began about 20 years before that. In 1962 Fred Hutchinson envisioned a center devoted to studying cancer, a disease that took his brother’s life. Today Fred Hutchinson is contributing to the next waves of breakthrough treatments and prevention strategies. Fred Hutchinson collaborates with the Seattle Cancer Alliance, the National Cancer Institute, and the University of Washington.