New York Blood Center

Quality Specialist II

US-NY-Long Island City
Job ID
2017-1808
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 Blood Manufacturing and Laboratory Services and be responsible for the effective implementation of the quality management system (QMS) at the NYBC. 

 

Responsibilities Include:

  • Protecting the safety of patients and blood donors by taking immediate action with input from a Quality Manager when there is a critical quality issue that warrants a stop to production and/or delivery of products and services.
  • Contributing to the design and participates 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 facilitating team projects as needed.
  • Coaching NYBC staff in GMP and quality principles and training staff in the 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 Medical Technology, Blood Banking or Transfusion Service laboratories preferred. Familiarity with NY State or CLIA regulations and FDA cGMPs for blood preferred.

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