• GMP Materials Specialist

    Job ID
    11941
    Type
    Regular Full-Time
    Company
    Fred Hutchinson Cancer Research Center
    Location
    US-WA-Seattle
    Category
    Manufacturing
  • 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 GMP Materials Specialist will provide direct technical and supervisory leadership to the group as well as indirectly to the entire cell therapy development and manufacturing organization.

    This position, reporting to the Sr. GMP Specialist, is responsible for the physical and administrative tasks involved in the receipt, labeling, storing and distribution of GMP and non-GMP materials.  Additional responsibilities will include the unpacking and verification of materials against purchase orders or invoices, the maintenance of records for received materials and the rejection of unsatisfactory items as necessary.

    Responsibilities

    • Support monitoring, ordering, receipt, inspection, and labeling of raw materials and supplies used in GMP manufacturing operations
    • Improve and maintain inventory control procedures and documentation for all raw materials and supplies
    • Work with key stakeholders to implement a new electronic inventory management system
    • Create and maintain material specifications for new and existing raw materials and supplies
    • Work with raw material suppliers to resolve material supply and quality-related issues
    • Maintain and organize GMP material storage areas
    • Create a system for “kitting” raw materials used in GMP manufacturing
    • Limited exposure to 2-8°C, -20°C, -80°C, and Liquid Nitrogen (-135°C) storage equipment/areas
    • Requires minimal handling of human cells, tissues, and cellular and tissue-based products to support operations
    • May supervisor material staff as required

    Qualifications

    • Bachelor’s degree or higher
    • A minimum of 3 years of GMP experience in warehouse operations, material handling, inventory control, etc.
    • Knowledge of handling temperature-sensitive products including receiving, storage, labeling and packaging
    • Ability to read, write, and interpret technical information and specifications in English
    • Self-motivated and detail-oriented with absolute adherence to all related procedures
    • Meets physical requirements of the job, as follows:  must have the ability to lift a minimum of 50 pounds, the ability to bend, reach, stretch, climb ladders and work in tight spaces in order to complete job tasks
    • Basic mathematical and organizational skills, good written and verbal communication skills and basic problem solving skills
    • Has a thorough understanding of cGMP requirements for clinical manufacturing
    • Basic computer proficiency working with MS office and database software
    • Ability to follow guidelines of the Standard Operating Procedures (SOPs) for each operation in the process to conform to the Good Manufacturing Practice (GMP) and the Food and Drug Administration (FDA) Regulations

    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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