Quality Assurance Specialist

3 weeks ago


New York, New York, United States New York Blood Center Full time
Quality Specialist II Job Description

At New York Blood Center, we are committed to cultivating excellence by merging cutting-edge innovation with diligent customer service, groundbreaking research, and comprehensive program and service development.

The Quality Specialist II plays a critical role in ensuring the quality and safety of products and services by applying knowledge of quality principles and practices to the design, implementation, control, monitoring, assessment, and continuous improvement of work processes.

Key Responsibilities:
  • Participate in the implementation and maintenance of the quality management system (QMS), with a focus on one or more program areas, including collection of blood and cellular therapy products, manufacturing and distribution, clinical services, transfusion services, laboratory services, and clinical research.
  • Protect 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.
  • Contribute to the design and participate in implementation and maintenance of the quality management system, including development, improvement and review of related SOPs, processes, IT solutions, and quality tools as assigned.
  • Independently perform quality assurance activities in support of NYBCe program areas.
Requirements:
  • Bachelor's degree in life sciences, pharmaceutical, biotech or biologics manufacturing, or quality management.
  • Minimum two years specialized experience in a healthcare or drugs/biologics/medical devices manufacturing setting.
  • Minimum four years total relevant experience, including any combination of specialized experience and clinical or technical work performed in a healthcare, laboratory, or drugs/biologics/medical devices manufacturing setting.

Salary: $80,000.00 - $90,000.00 per year, depending on location and experience.



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