• QA Associate II, HVTN Laboratory Sciences

    Job ID
    14449
    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 Quality Assurance (QA) Associate will be responsible for participating in the development, implementation and maintenance of quality assurance systems and activities related to all aspects the Seattle HVTN Immunological Endpoint Assay, Seattle Research & Development, and Specimen Processing Laboratories. The incumbent will work under the direction of the HVTN Lab QA Program Manager. QA Associate II designation will be based on candidate’s qualifications and related experience.

    • Conduct internal laboratory audits to ascertain that all activities conform to Good Clinical Laboratory Practices (GCLP) guidance. Host external (e.g. study sponsor) audits, facilitating audit related interviews with internal subject matter experts and laboratory leadership.
    • Formally document internal audit findings and report to HVTN Laboratory Program Director. Coordinate laboratory efforts in responding to external audit findings; compile replies in appropriately formatted responses.
    • Facilitate compliance issue resolutions and incident management with laboratory leadership and staff, as appropriate. Provide recommendations and communicate status of action resolution; track corrective actions for effectiveness.
    • Maintain electronic QA systems (e.g. document control). Coordinate/participate in efforts related to implementation of new electronic QA systems as required.
    • Audit final study reports to ascertain that the report reflects the raw data of the study.
    • Monitor and maintain electronic and hard-copy archives of source documents in compliance to GCLP guidance.
    • Assess clarity, adequacy, and GCLP-compliance of new and revised operational standard operating procedures (SOPs); maintain related document control.
    • Facilitate internal and external proficiency/quality assurance investigation and corrective actions for any unacceptable results.
    • Work collaboratively with the HVTN Central Quality Assurance Program. Interact with QA mangers at other similar network laboratories to help ensure compliance with HVTN procedures/conventions and DAIDS GCLP guidelines.
    • Support quality assessment and improvement activities for the network; provide consultative services as appropriate.

    Qualifications

    Minimum Qualifications

    • BS or MS degree in an appropriate scientific field.
    • Familiarity with regulatory requirements for laboratory-performing clinical studies
    • Minimum 5 years of experience working in a GCLP, GLP and/or GMP regulated setting

    Preferred qualifications

    • Membership/certification in SQA (Society for Quality Assurance) strongly preferred
    • Familiarity with cellular immune monitoring techniques
    • Experience in immune monitoring of vaccine clinical trials or vaccine development
    • Experience in validation of biological methods

    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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