Versiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute, we enable life saving gifts from our donors, and provide the science behind the medicine through our diagnostic laboratories. Versiti brings together outstanding minds with unparalleled experience in transfusion medicine, transplantation, stem cells and cellular therapies, oncology and genomics, diagnostic lab services, and medical and scientific expertise. This combination of skill and knowledge results in improved patient outcomes, higher quality services and reduced cost of care for hospitals, blood centers, hospital systems, research and educational institutions, and other health care providers. At Versiti, we are passionate about improving the lives of patients and helping our healthcare partners thrive.

Under the direction of the MSI Manager, Operational Excellence, assists in providing quality systems, compliance, and continuous improvement support for day to day operations within Cellular Therapy Program which includes Cellular Therapy Laboratory, Cord Blood Bank, and Therapeutic Services. Works collaboratively with Versiti operational teams and leadership as well as key corporate teams including Quality and Regulatory, Quality Management Systems, and Continuous Improvement teams to support quality improvements and ensure regulatory and accreditation compliance.

Supports change control activities, validations, development of new, and revision of existing SOPs and related documents across the Cellular Therapy Program including training needs assessments and assignments. Represents Cellular Therapy Program when collaborating on Versiti level documents and training.
• Creates and assists in maintenance of centralized files on training, LMS administration, event management, and equipment management. Performs process, equipment, and/or chart audits for the Cellular Therapy Program.
• Effectively gathers and analyzes data including defined key performance and quality indicators to accurately & clearly demonstrate performance and identify areas for improvement. Prepares quality metric reports in support of accreditation and regulatory requirements.
• Leads and/or facilitates quality and process improvement efforts, risk assessments, error/deviation investigations, and corrective/preventive action teams within the department, and cross functionally within Versiti as required, utilizing Lean, Six Sigma, and other process improvement tools to reach desired outcomes.
• Supports both internal and external audits including implementation and follow up of corrective, preventive, and effectiveness check actions to address gaps or findings.
• Supports in the evaluation and implementation of new software systems as well as on-going maintenance, improvements, and use of enterprise Quality Management System software. Assists users to ensure that defined functions are used in Cellular Therapy and Therapeutic Services.
• Serves as Quality Manager for applicable accrediting agencies, such as FACT and AABB to establish and maintain systems to review, modify, and approve all policies and SOPs intended to monitor compliance with standards and regulations.
• Appropriately allocates time and resources when serving on project teams to deliver on deadlines and to assist in the achievement of department goals and objectives in support of the vision and mission of Versiti.
• Supports the development and delivery of training and education in quality management systems, quality and regulatory requirements, and continuous improvement methods and tools to department management and staff.
• Performs other duties as required or assigned which are reasonably within the scope of the duties in this job classification
• Understands and performs in accordance with all applicable regulatory and compliance requirements
• Complies with all standard operating policies and procedures

Education

• High School Diploma or equivalent required
• Bachelor's Degree from an accredited college or university in clinical laboratory science or science related degree (biology, chemistry, molecular biology, immunology, or related field) required

Experience

• 1-3 years experience with a required Bachelor's degree in regulated environment where change management, validation, and controlled document development has been required and successfully implemented required
• 1-3 years experience as a technical writer, documentation specialist, or writing documents in standard format required
• Experience in a role successfully participating in Six Sigma, Lean, or Continuous Improvement preferred
• Experience in data analysis and making recommendations for process improvement preferred
• Experience working in a regulated pharmaceutical or medical environment preferred

Knowledge, Skills and Abilities

• Strong analytical skills and attention to detail required
• Knowledge of and ability to apply quality management/process improvement tools including LEAN, root cause analysis, and use of statistics required
• Excellent organizational skills with ability to handle and prioritize multiple tasks at one time required
• Ability to adapt to work flow interruptions and sudden changes in routine work habits required
• Knowledge of federal, state, and accrediting agency regulations, especially FDA (Food and Drug Administration), AABB (Association for the Advancement of Blood and Biotherapies), FACT (Foundation for the Accreditation of Cellular Therapy) and NMDP (National Marrow Donor Program) preferred
• Excellent technical writing and editing skills in writing department operating procedures, quality documents, and reports required. Excellent written and verbal communication skills required
• Strong computer skills (Word, Excel, Visio), and the ability to learn and effectively use additional computer software required

Licenses and Certifications

• Quality certification i.e. ASQ CQA, ASQ CQE, etc. within 1 Year preferred
• Six Sigma belt certification i.e. Yellow Belt within 1 Year preferred

Tools and Technology

• Personal computer and software tools including word processing, spreadsheets, databases, and statistical analysis tools required

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