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.
The Quality Specialist II works 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. The incumbent is responsible for the effective implementation of the quality management system (QMS), with a focus on one or more program areas, including blood and cellular therapy products manufacturing and distribution, clinical services, transfusion services, laboratory services, and clinical research, as well as organization-wide support functions such as information systems, facilities, and safety.
Protects the safety of patients and blood or HCT/P 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.
Contributes 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.
Ensures that appropriate specifications for NYBC services and products have been defined according to their intended use and verifies that they consistently meet these defined specifications.
Reviews and approves validation studies for critical processes, equipment, and computer systems to assure that they will consistently perform as expected.
Coaches NYBC staff in GMP and quality principles and trains staff in the use of quality tools.
Minimum of bachelor’s degree in life sciences, pharmaceutical, biotech or biologics manufacturing, or quality management. Bachelor’s degree in another field of study may be considered with strong, relevant work experience.
Minimum two years specialized experience (includes performing activities of a quality professional in a healthcare or drugs/biologics/medical devices manufacturing setting). A working knowledge of quality assurance methods, principles, and practices, including basic statistical analysis and sampling techniques, auditing, process control, validation, and process improvement methodologies.
Unless otherwise specified, all posted opportunities are located in the New York or Greater Tri-State office locations