Fred Hutchinson Cancer Research Center & Seattle Cancer Care Alliance

  • Document Control Specialist I

    Job ID
    12578
    Type
    Regular Full-Time
    Company
    Seattle Cancer Care Alliance
    Location
    US-WA-Seattle
  • 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 Cellular Therapeutics Department (CTP) at SCCA is one of the largest cell therapy facilities in the United States and is on the cutting edge of new technologies for cancer therapy, including cell-based immunotherapy. We are committed to advancing treatment options for our patients through the translation of innovative research into clinical practice. We collaborate with our Alliance members (University of Washington, FHCRC and Seattle Children’s Hospital) as well as corporate entities.

     

    CTP is responsible for apheresis, bone marrow harvest and all minimally manipulated therapeutic cell processing occurring at the SCCA for standard practice as well as clinical trials. Processing procedures range from cryopreservation and flow cytometric enumeration of cell proportions to more complex procedures such as cell selection, enrichment, and depletion. The laboratory is regulated by the FDA cGTP/cGMP standards, maintains College of American Pathologists (CAP) certification, and is accredited by the Joint Commission and the Foundation for the Accreditation of Cell Therapy (FACT).

     

    The Quality Assurance Document Control Specialist is an integral member of the CTP team, collaborating across both the Apheresis Group (APH) and Cell Therapy Laboratory (CTL) as well as across organizations within and outside the Alliance. The primary responsibility of this position is to own and operate our department specific document control system. This is a hybrid electronic/manual system exclusive to the SCCA CTP. The position reports to the CTP Regulatory Compliance Manager. Regular interactions with medical, scientific and laboratory staff provide a stimulating and diverse environment.

    We are seeking a highly motivated individual with initiative, excellent communication and collaboration skills, consummate professionalism and attention to detail. Previous experience with Document Control in medical, pharmaceutical or biotechnology industry is preferred. The qualified applicant should be dedicated to serving patients and SCCA’s vision to lead the world in translating scientific discovery into the prevention, diagnosis, treatment, and cure of cancer. The qualified applicant will be someone who is at ease working either independently or as part of a team.

    Responsibilities

    • Own, operate and maintain SCCA Cellular Therapeutic's Document Control system
    • Performs technical writing and clerical/general departmental support for the preparation/edit of standard operating procedures (SOP) and other controlled documents.
    • Maintain master files for controlled documents. Coordinate and perform document processing activities such as tracking status, initiating document revisions, issuing/distributing for approval and employee review and assuring implementation of documents.
    • Maintain all paper systems according to cGTP regulatory and FACT accreditation requirements including the distribution and reconciliation of controlled documents.
    • Archiving obsolete documents.
    • Coordinate biannual review process for SOPs, Batch Records, and Batch Record Worksheets.
    • Perform quality control checks of paper and electronic files.      
    • Purchase office supplies for CTP Quality group and performs inventory control.
    • Develop and maintain effective working relationships with a variety of colleagues and stakeholders, including cross-functionally
    • Identify process improvements, facilitate development and documentation
    • Maintain understanding of applicable regulations, standards, terminology and practice at a level to be able to work effectively with CTP colleagues. This includes learning about new cell-based therapeutics entering clinical trials in which CTP participates.

    Qualifications

    Required:

    • High School Diploma or equivalent
    • At least three years of progressively complex administrative experience or equivalent
    • Strong skills with Microsoft Word, Excel, Outlook and Access
    • Excellent attention to detail
    • Outstanding organizational skills
    • Outstanding communication skills
    • Collaborative
    • Must be flexible, willing and able to work in team-based environment

    Preferred:

    • BA/BS
    • One or more years of experience in the biotechnology or medical/pharmaceutical field

    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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