• Clinical Technologist II - Certified (Quality)

    Job ID
    14012
    Type
    Regular Full-Time
    Company
    Seattle Cancer Care Alliance
    Location
    US-WA-Seattle
    Category
    Quality
  • Overview

    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 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 Point of Care Testing (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 Laboratory 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.

     

    Shift Schedule: M-F; 12:00pm - 9:00pm

    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 Procedures.

    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

     

    Cellular Therapeutics Quality

    • Review product processing records to ensure compliance with standard operating procedures and release criteria
    • Perform product release
    • Review, evaluate and investigate deviations; coordinate corrective actions with Operational staff. Work with Operational management to properly close variances.
    • 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.
    • Perform other assignments as assigned.

    Qualifications

    Required:

    • 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.
    • Minimum of 2 years of clinical lab or research experience
    • Medical Laboratory Scientist, Medical Technologist or an equivalent certification through ASCP or AMT.
    • Proficient with the MS Office Suite
    • 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
    • Shares learned information Performs laboratory quality controls measurements
    • Ability to organize and manage time and tasks independently


    Preferred:

    • Knowledge and understanding of applicable laboratory regulations
    • Familiarity with medical terminology
    • Ability to interpret applicable regulations (FDA/FACT/CAP/CLIA/DOH/ASHI)

    Our Commitment to Diversity

    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 escmail@fredhutch.org or by calling 206-667-4700.

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