Job Description

Responsibilities

The Quality Specialist I or II works to ensure 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. The incumbent participates 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, as well as organization-wide support functions such as information systems, facilities, and safety.

Primary Responsibilites:

Quality Specialist I

• Protects the safety of patients and blood or HCT/P donors by providing timely information to a Quality Manager when there is a critical quality issue that warrants a stop to production and/or delivery of products and services.
• Participates in the implementation and maintenance of the quality management system, including development, improvement and review of related SOPs, processes, IT solutions, and quality tools as assigned.
• Performs quality assurance activities in support of NYBC-enterprise program areas.
• Ensures that appropriate specifications for NYBCe services and products have been defined according to their intended use.
• 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 validation studies for critical processes, equipment, and computer systems to assure that they will consistently perform as expected.
• Qualifies outside supplier of reagents, materials and services used in critical processes according to NYBCe standards.
• Assists operational staff in the identification and reporting of deviations.
• Assists operational staff in root cause analysis, and the development of effective corrective action, preventive action, and effectiveness verification plans.
• Provides support for external regulatory and accreditation inspections, including preparation and follow up activities.
• Performs record reviews to verify that products/services meet defined specifications prior to release, as assigned.
• Processes quality event reports such as adverse events, lookbacks, post-donation information, and complaints, as assigned.
• Monitors and assesses quality performance and compliance of operational systems.
• Tracks deviation reporting process, including classification, analysis and follow up.
• Participates in quality audits and in process assessments, as assigned.
• Participates in focused quality assessments of operational processes.
• Tracks, trends, and creates reports of quality process performance data.
• Contributes to process improvement efforts.
• Reviews corrective action and preventive action plans to ensure they are adequate.
• Performs verification and effectiveness checks for CAPAs.
• Identifies opportunities for improvement and makes recommendations based on monitoring and assessment activities.
• Participates in formal process improvement team projects as assigned.
• Participates in regularly scheduled quality management system review meetings with operational staff and managers.
• Assists in training NYBCe staff in GMP and quality principles and in the use of quality tools.

Primary Responsibilites:

Quality Specialist II

• 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 and maintenance of the 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 NYBCe program areas.
• Ensures that appropriate specifications for NYBCe services and products have been defined according to their intended use.
• 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 to assure that they will consistently perform as expected.
• Qualifies outside suppliers of reagents, materials and services used in critical processes according to NYBC standards.
• Assists operational staff in the identification and reporting of deviations and other quality events.
• Advises and supports 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.
• Performs record reviews to verify that products/services meet defined specifications prior to release, as assigned.
• Manages quality events such as adverse events, lookbacks, post-donation information, and complaints.
• Performs and approves consignee notification and FDA reporting of errors.
• Independently monitors and assesses quality performance and compliance of operational systems.
• Manages deviation reporting process, including classification, analysis and follow up.
• Leads 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.
• Leads or participates in 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 NYBCe staff in GMP and quality principles. Advises staff regarding regulatory and quality issues, and facilitates staff awareness, training, and understanding of applicable regulations. Trains staff in the use of quality tools.
• Provides Quality and GMP training for new employees, as assigned.

Qualifications

Educational Requirements:

Quality Specialist I: Associate Degree in life sciences, pharmaceutical, biotech or biologics manufacturing, or quality management may be considered with strong relevant experience.

Minimum two years relevant experience includes any combination of:

• specialized experience as a quality professional, preferably in a healthcare or drugs/biologics/medical devices manufacturing setting, or clinical or technical work performed in a healthcare, laboratory, or drugs/biologics/medical devices manufacturing setting.

Quality Specialist II: Bachelor's degree in life sciences, pharmaceutical, biotech or biologics manufacturing, or quality management.

• ASQ, Six Sigma or Lean Certification is a plus.

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).

Any combination of education and experience equivalent to the requirements listed above has supplied the necessary knowledge, skills, and experience to perform the essential functions of the job equivalent to the job requirements above.

Valid driver’s license with an acceptable driving record preferred.

This is an in-office position.

The proposed salary for the Quality Specialist I position is $57,530 to $63,000/Yr

The proposed salary for the Quality Specialist II position is $68,000 to $78,000/Yr

Offers made to an individual candidate will depend on a variety of factors, including experience, skills, and job-related education.

Founded in 1979, Rhode Island Blood Center (RIBC) has served Rhode Island and the New England area for more than 45 years, delivering more than 90,000 lifesaving blood products annually to 50+ hospitals, EMS and healthcare partners. RIBC 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. RIBC serves as a vital community lifeline dedicated to helping patients and advancing global public health. To learn more, visit ribc.org. Connect with us on Facebook, X, Instagram, and LinkedIn.