New York Blood Center and Rhode Island Blood Center

  • Quality Specialist II

    Job Locations US-NY-New York
    Job ID
    2019-2164
    Category
    Quality Assurance
    Type
    Regular Full-Time
  • Overview

    At New York Blood Center, one of the most comprehensive blood centers in the world, our focus is on cultivating excellence by merging cutting-edge innovation with diligent customer service, groundbreaking research, and comprehensive program and service development. Join us as we work towards meeting and exceeding the growing needs of our diverse communities, further our lifesaving strategic goals in a rapidly changing environment, and expand our impact on the local, national, and global communities we serve.

    Responsibilities

    In this role, you will work to ensure the quality and safety of NYBC products and services by applying expert knowledge of quality principles and practices to the design, implementation, control, monitoring, assessment and continuous improvement of work processes. You will provide quality support for Medical Programs and Services functional areas, including clinical apheresis, peri-operative auto-transfusion services and cellular therapy programs.

     

    Responsibilities Include:

    • Protecting the safety of patients and blood or HCT/P donors by notifying management and taking immediate action when a critical quality issue is identified that may warrant a stop to production and/or delivery of products and services.
    • Contributing to the design and taking a lead role in implementation of NYBC’s quality management system, including development, improvement and review of related SOPs, processes, IT solutions and quality tools as assigned.
    • Independently performing quality assurance activities in support of NYBC program areas.
    • Independently monitoring and assessing quality performance and compliance of operational systems.
    • Contributing to process improvement efforts and leading team projects as needed.
    • Advising and training NYBC staff in GMP and quality principles and in use of quality tools.

    Qualifications

    To qualify, you must have a Bachelor’s degree in life sciences, pharmaceutical, biotech or biologics manufacturing, or quality management. A minimum of 2 years’ of specialized experience (includes performing activities of a quality professional in a healthcare or drugs/biologics/medical/devices manufacturing setting) and a minimum of 4 years’ total of relevant experience (includes any combination of specialized experience and clinical or technical work performed in a healthcare, laboratory, or drugs/biologics/medical/devices manufacturing setting) is required. Knowledge of quality assurance methods, principles, and practices is essential. Excellent oral/written communication, multi-tasking, problem-solving and organizational skills will be expected. Background in Clinical Apheresis, Medical Technology, Blood Banking and/or Cellular Therapy Processing laboratories preferred. Familiarity with FDA cGTPs for HCT/P, AABB/FACT standards for cell therapy preferred.

     

    Unless otherwise specified, all posted opportunities are located in the New York or Greater Tri-State office locations

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