• QA Associate II, HVTN Laboratory Operations

    Job ID
    14450
    Type
    Regular Full-Time
    Company
    Fred Hutchinson Cancer Research Center
    Location
    US-WA-Seattle
    Category
    Quality
  • Overview

    Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

     

    The HIV Vaccine Trials Network (HVTN) Laboratory Center is part of an international collaboration of scientists and educators searching for effective and safe vaccines. The HVTN’s mission is to facilitate the process of testing preventive vaccines against HIV/AIDS and related infectious diseases. The organization conducts all phases of clinical trials from evaluating experimental vaccines for safety and the ability to stimulate immune responses through to testing vaccine efficacy. The Laboratory Center is responsible for carrying out the scientific agenda of the HVTN by conducting laboratory-based studies to evaluate the immunogenicity of investigational vaccines.

    Responsibilities

    The focus of responsibilities for the QA Associate II is to provide oversight, coordinate and facilitate clinical site specimen processing and clinical testing lab projects and programs for the HVTN Laboratory Operations Division. QA Associate I vs. II designation will be based on candidate’s qualifications and related experience.

     

    The QA Associate will provide QA oversight to processing labs associated with HVTN clinical trials by:

     

    • Providing oversight for domestic and international network site labs for HVTN study preparation: providing site training, developing and communicating study-related lab practices and operations, and determining network lab equipment needs. The QA Associate will monitor Good Clinical Laboratory Practice compliance, workload, and other key quality indicators that may impact deliverables.
    • Providing input and support to other divisions within the HVTN and client protocol teams for specimen processing, storage and shipping, as well as clinical lab testing/methodologies.
    • Facilitating implementation of specimen management programs for study related specimens including data entry and electronic systems support.
    • Providing oversight for specimen processing and cryopreservation training and certification program.
    • Providing peripheral blood mononuclear cell (PBMC) External Quality Control program support including analysis, interpretation and reporting to sites.  Review adequacy of site response on EQC reports.
    • Create additional quality assurance programs for other specimen types.
    • Collaborating with other divisions within the HVTN to support network clinical trials and representing the HVTN Lab Center in interactions with stakeholders.
    • Providing network lab support and training through regular site visits, conference calls, or other appropriate media. Must be able to adapt communication styles based on targeted audience and topic.
    • Assisting site labs with implementation of individualized Quality Assurance plans and related QA systems, such as local document control and equipment maintenance programs.
    • Coordinating, participating in, and supporting the efforts of the HVTN Laboratory Program and performing additional activities as necessary.

    Qualifications

    Minimum qualifications

    • B.A./B.S. in a medical science field
    • Minimum 5 years of experience in clinical safety laboratory
    • Experience in Good Clinical Laboratory Practices (GCLP), clinical laboratory quality assurance
    • Demonstrated experience in clinical safety laboratory management
    • Ability to work with minimal supervision

    Preferred qualifications

    • At least 5 years of experience as a medical laboratory scientist or equivalent strongly preferred
    • At least 1 year of laboratory experience focused in quality assurance
    • Understanding of HIV diagnostics testing
    • Demonstrated experience with PBMC (peripheral blood mononuclear cell) processing and storage and clinical trials
    • Computer skills – including Microsoft Word, Excel, PowerPoint and laboratory-specific programs
    • Good numeracy, literacy and organizational skills
    • Good interpersonal communication and time management skills
    • Willingness to be flexible in working hours, be willing to travel as needed, and work some evenings and weekends
    • Fluency in Spanish

    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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