Fred Hutchinson Cancer Research Center & Seattle Cancer Care Alliance

Clinical Quality Technologist II - Certified

Job ID
21822
Type
Regular Full-Time
Company
Seattle Cancer Care Alliance
Location
US-WA-Seattle

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 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.

Responsibilities

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


POCT

  • 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

Qualifications

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.


Experience:

  • 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.

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