• QA Associate II

    Job ID
    13039
    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 Program is part of an international collaboration of scientists and educators searching for an effective and safe HIV vaccine. The HVTN’s mission is to facilitate the process of testing preventive vaccines against HIV/AIDS. The organization conducts all phases of clinical trials from evaluating experimental vaccines for safety and the ability to stimulate immune responses to testing vaccine efficacy. The Laboratory Program is responsible for carrying out the scientific agenda of the HVTN in determining by laboratory based studies which vaccine regimens should be advanced for efficacy trials and show promise for licensure. This effort includes leading a number of working groups, committees, specimen repository oversight, assay performance and quality assurance.

    Responsibilities

    Under the direction of the HVTN Associate Director for Laboratory Operations and the HVTN QA/QC Project Manager, the QA/QC (Quality Assurance & Quality Control) 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 and Specimen Processing Laboratories. This will include but is not limited to the duties described below.

    • Conduct laboratory audits and informal inspections to ascertain that all activities conform to Good Clinical Laboratory Practices (GCLP) standards.
    • Coordinate with the laboratory manager and related stakeholders to describe or determine the scope, objective(s), and scheduling of internal and external (e.g., study sponsor) audits.
    • Perform periodic internal audits
    • Formally document audit findings and report to HVTN Laboratory Program Director.
    • Facilitate compliance issue resolutions and incident management with laboratory managers and staff, as appropriate. Provide recommendations, communicate status of action resolution, and bring to management issues that require attention; track corrective actions for effectiveness.
    • Maintain electronic QA systems (e.g. document control).
    • Audit final study reports to ascertain that the report reflects the raw data of the study.
    • Monitor and maintain archives of pertinent documents for their adherence to GCLP principles.
    • Assess clarity, adequacy, and GCLP-compliance of new and revised SOPs. Maintain document control and historical archive of SOPs.
    • Obtain documented commitments for corrective actions and associated follow up to verify implementation of any such measures.
    • Facilitate internal and external proficiency/quality assurance testing/evaluation.
    • Host external regulatory inspections and audits.

     

    In addition, the QA/QC Associate will work collaboratively with the central HVTN Quality Assurance Program. This includes interacting with QA mangers at network laboratories to help ensure compliance with HVTN procedures and DAIDS GCLP guidelines. Central QA activities will include but are not limited to:

    • Collaborate in the development, implementation, control and distribution of Standard Operating Procedures (SOPs).
    • Support of quality assessment and improvement activities for the Network; provide consultative services as appropriate.

    Qualifications

    • BS or MS degree in an appropriate scientific field. Membership/certification in SQA (Society for Quality Assurance) strongly preferred.
    • Familiarity with regulatory requirements for laboratory-based immunogenicity studies
    • Experience working in a GCLP, GLP and/or GMP regulated setting
    • Familiarity with cellular immune monitoring techniques preferred
    • Experience in immune monitoring of vaccine clinical trials or vaccine development preferred.

    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.

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed