Overview

The Quality Specialist I ensures 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. 

Some duties of this position may be “essential” during severe weather or emergency operation events; however, they can typically be performed remotely.

Responsibilities

The incumbent participates with quality management system (QMS), with a focus on one or more program areas, including 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. 

• Protects the safety of patients and blood or donors by providing timely information to the Director of Quality and Regulatory Affairs or other key leadership staff when there is a critical quality issue that warrants a stop to production and/or delivery of products and services.
• Serves as BBD’s eQMS (electronic Quality Management System) Sub Administrator. Tasks performed include but are not limited to employee on boarding and off-boarding, end-user support and troubleshooting, conducting employee training in eQMS applications and use, and user management (roles & rights). Additionally, generating system reports in conjunction with NYBCe team, leading BBD in eQMS projects such as implementation of new applications and system upgrades, including development and execution of UAT (user acceptance testing), validation plans, and validation test cases as well as and general management of applications (i.e. Documents, Training, FBS forms, Custom forms, Audits, STRAE (adverse event reports), PDI (post-donation information), RIR (reaction and injury reports), Customer Complaints). 
• Serves as Business Partner to designated BBD department(s).
• Performs quality assurance activities in support of BBD program areas.
  • Confirms that operational SOPs comply with applicable regulations, accreditation standards, and current BBD 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.
  • 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.
• Monitors and assesses quality performance and compliance of operational systems.
  • Tracks deviation reporting process, including classification, analysis and follow up
  • Participates in quality audits
  • Participates in in-process reviews of operational processes
  • Tracks, trends, and reports quality and 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 on formal process improvement team projects as assigned.
  • Participates in regularly scheduled quality system review meetings with operational staff and managers.
• Assists in training BBD staff in GMP and quality principles and in the use of quality tools

Qualifications

Education:

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.

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

Related 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).

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.