Quality Specialist II

Responsibilities

• Works to ensure the quality and safety of products and services by applying knowledge of quality principles and practices.
• Participates in the implementation and maintenance of the quality management system (QMS).
• Protects the safety of patients and blood or HCT/P donors by taking immediate action with input from a Quality Manager.
• Designs, implements, and maintains quality management system processes, including development, improvement, and review of related SOPs, processes, IT solutions, and quality tools.
• Performs quality assurance activities in support of NYBCe program areas.
• Ensures that appropriate specifications for NYBCe services and products have been defined.
• Verifies that products and services consistently meet defined specifications.
• Confirms that operational SOPs comply with applicable regulations, accreditation standards, and current NYBCe policy.
• Verifies that document management and record keeping systems comply with regulatory and accreditation requirements.
• Reviews and approves validation studies for critical processes, equipment, and computer systems.
• Qualifies outside suppliers of reagents, materials, and services used in critical processes according to NYBC standards.
• Aids operational staff in identifying and reporting deviations and other quality events.
• Assists in root cause analysis and the development of effective corrective action, preventive action, and effectiveness verification plans.
• Facilitates external regulatory and accreditation inspections, including preparation and follow-up activities.
• Monitors and assesses quality performance and compliance of operational systems.
• Manages deviation reporting process, including classification, analysis, and follow-up.
• Led or participates in quality audits.
• Performs focused quality assessments of operational processes.
• Tracks, trends, analyzes, and creates reports of quality and process performance data.
• Contributes to process improvement efforts and facilitates team projects as needed.
• Advises staff on the development of corrective action and preventive action plans.
• Performs verification and effectiveness checks for CAPAs.
• Identifies opportunities for improvement and makes recommendations based on monitoring and assessment activities.
• Led or participates in formal process improvement team projects as assigned.
• Led or actively participates in regularly scheduled quality management system review meetings with operational staff and managers.
• Trains staff in the use of quality tools.
• Provides Quality and GMP training for new employees, as assigned.

Qualifications

• Bachelor's degree in life sciences, pharmaceutical, biotech or biologics manufacturing, or quality management.
• Minimum two years specialized experience (includes performing activities of a quality professional in a healthcare or drugs/biologics/medical devices manufacturing setting).
• Minimum four years total relevant experience (includes any combination of: specialized experience described above, and Clinical or technical work performed in a healthcare, laboratory, or drugs/biologics/medical devices manufacturing setting).
• ASQ, Six Sigma or Lean Certification is a plus.
• Valid driver’s license with an acceptable driving record.

Overview
Founded in 1964, New York Blood Center (NYBC) has served the tri-state area for more than 60 years, delivering 500,000 lifesaving blood products annually to 150+ hospitals, EMS and healthcare partners. NYBC is part of New York Blood Center Enterprises (NYBCe), which spans 17+ states and delivers one million blood products to 400+ U.S. hospitals annually. NYBCe additionally delivers cellular therapies, specialty pharmacy, and medical services to 200+ research, academic and biopharmaceutical organizations. NYBCe’s Lindsley F. Kimball Research Institute is a leader in hematology and transfusion medicine research, dedicated to the study, prevention, treatment and cure of bloodborne and blood-related diseases. NYBC serves as a vital community lifeline dedicated to helping patients and advancing global public health. To learn more, visit nybc.org.
Connect with us on Facebook, X, Instagram, and LinkedIn.