• 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.
• Independently performs quality assurance activities in support of NYBC program areas.
  • 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.
  • Confirms that operational SOPs comply with applicable regulations, accreditation standards, and current NYBC 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 to assure that they will consistently perform as expected.
  • Verifies that outside suppliers of reagents, materials and services used in critical processes are qualified according to NYBC standards.
  • Assists operational staff in the identification and reporting of deviations.
  • As operational staff 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.
• Independently monitors and assesses quality performance and compliance of operational systems.
  • Manages deviation reporting process, including classification, analysis and follow up
  • Participates in quality audits
  • Performs in-process reviews of operational processes
  • Tracks, trends, analyzes and reports 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.
  • Participates on formal process improvement team projects as assigned.
  • Leads or actively participates in regularly scheduled quality management system review meetings with operational staff and managers.

• 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.

Minimum four years total relevant experience (includes any combination of: 1) specialized experience described above, and 2) clinical or technical work performed in a healthcare, laboratory, or drugs/biologics/medical devices manufacturing setting).

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