• Clinical Quality Assurance Specialist

    Job ID
    14027
    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 Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is seeking a Clinical Quality Assurance Specialist to join the Quality Assurance Team to provide quality support of clinical trial research.

    Responsibilities

    Works with the Quality Assurance Team to develop, implement, maintain and monitor the comprehensive quality management system (QMS), including

    • SOP Document Control
    • Employee SOP/Compliance Training
    • Record Maintenance
    • CAPA Implementation and Reporting
    • Internal Quality Audits
    • External Audits and Inspections
    • Vendor Audits
    • System Validation Review and Archive
    • Quality Department Process Improvement Initiatives
    • Org Charts, CVs, Job Descriptions, Debarment Checks Maintenance
    • Performs other responsibilities as required

    Qualifications

    Bachelor's degree* with 2+ years of experience implementing typical quality assurance activities, including:

    • Facilitating internal audits of processes, study documentation, and records, as well as, maintenance of related records.
    • Preparing and/or participation in client or regulatory audits and maintenance of related records.
    • Identification and reporting of incidents/deviations, maintenance of related reports and documents, implementation of corrective and/or preventive actions.
    • Assignment and tracking of staff training and maintenance of training records.
    • Review, development and revision of procedures (SOPs), as well as, maintenance of controlled documents and related records.
    • Qualification of suppliers/vendors and maintenance of related documentation.
    • Review of system validation documentation and maintenance of related records.

    *Progressive experience in implementing quality systems may substitute educational requirement.

     

    Seeking Key Characteristics

    • Effective written and verbal communication skills 
    • Proficiency in MS Office Applications
    • Ability to multi-task and meet target dates
    • Strong organizational skills
    • Ability to maintain accurate and detailed records

    Preferred Experience, but not required

    • Familiarity with Good Clinical Practices (GCP) in a clinical trial atmosphere
    • Experience using MasterControl or similar eQMS system

    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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