Laboratory Process Improvement Specialist - New York Blood Center Inc

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.

Maintains quality standards in the laboratory setting, including but not limited to compliance with regulatory requirements, preparing validations, process improvement initiatives, and deviation management. Provides administrative support, including attending organizational wide meetings as the department representative.

• Responsible for monitoring and maintaining laboratory quality for Immunohematology, Frozen Blood, and Genomics Laboratories.
• Ensures compliance with NYSDOH, CLIA, AABB, and FDA regulations.
• Prepares and monitors change control and validation plans.
• Prepares and implements Standard Operating Procedures (SOPs) with input from laboratory management and staff.
• Compiles data for and monitors quality indicators.
• Serves as liaison between the lab and quality team during laboratory inspections.
• Monitors continuing education, training, and competency for staff.
• Assures new employees meet requirements for education and experience and complete orientation and training prior to working independently.
• Performs departmental orientation for new employees.
• Coordinates training schedules for Transfusion Medicine fellows, visitors, and students.
• Provides administrative support as needed.
• Represents department at NYBCe organizational meetings.
• Monitors and documents errors, omissions, and incidents and initiates deviation report and performs root cause analysis.
• Prioritizing and coordinating projects and meetings
• Prepare validation protocols for information systems or processes/testing or equipment.
• Ensure process efficiencies:
  • By assisting department management with staff development.
  • By ensuring staff fulfills required continuing education, training, and competency.
• Make recommendations to improve business unit operations.
• Attend meetings as necessary.
• Any related duties as assigned.

Education:

• Bachelor’s Degree in biological sciences, or related area.

Experience:

• 3 years of experience in clinical, pharmaceutical, biotech or biologics manufacturing quality management.

For applicants who will perform this position in New York City or Westchester County, the proposed annual salary is $65,370.00p/yr. to $98,050.00p/yr. For applicants who will perform this position outside of New York City or Westchester County, salary will reflect local market rates and be commensurate with the applicant’s skills, job-related knowledge, and experience.

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