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.

PRINCIPAL ACCOUNTABILITY Under the direction of the Director, Diagnostic Laboratories Operational Excellence, provides oversight/administration of quality systems and enterprise quality management software within the Diagnostic Laboratories. Works collaboratively with DL Medical/CLIA Directors, DL leadership and staff, as well as key corporate teams including Quality and Regulatory, Quality Management Systems, IS/LIS, and Continuous Improvement to provide consultative expertise to laboratory operational departments to achieve process control, continuous improvement, customer satisfaction, and overall operational effectiveness/quality with respect to compliance with regulations, safety, and quality measurements within the day to day operations of the laboratories.

Benefits
Versiti provides a comprehensive benefits package based on your job classification. Full-time regular employes are eligible for Medical, Dental, and Vision Plans, Paid Time Off (PTO) and Holidays, Short- and Long-term disability, life insurance, 7% match dollar for dollar 401(k), voluntary programs, discount programs, others.

• Position will have specific focus in supporting the Transfusion Service at Children's Hospital and the Immunohematology Reference Labs (IRLs) across the Versiti footprint with a small amount of routine travel to IL, IN, MI, and OH. This position has developed and demonstrated a high level of immunohematology/transfusion technical competence that allows for completing work in a highly independent and efficient manner, handling complex quality issues. 
• Serves as a primary resource within the Diagnostic Laboratories in the review and assessment of current standards and regulations to ensure compliance is maintained in daily operations.
• Develops, oversees, and assists departments with tracking quality system related items and metrics including audit findings, proficiency testing results, incident/event management, training/competency assessment, change control, validation. Partners with operations to determine necessary corrective and preventative actions and to ensure deviations are appropriately documented and managed within the eQMS.
• Leads and/or facilitates quality and process improvement efforts, risk assessments, error/deviation investigations, and corrective/preventative action teams within the Diagnostic Laboratories, and cross functionally within Versiti as required, utilizing, Lean, Six Sigma, and other process improvement tools to reach desired outcomes.
• Effectively gathers, analyzes, prepares, and reports out on data including defined key performance and quality indicators, to accurately & clearly demonstrate performance. Identifies trends, assesses for impact and risk, and leads implementation of corrective/preventative actions and process improvement opportunities. Performs final review of, and serves as point of contact for quality metric reports in support of business development and customer requests.
• Leads implementation, ongoing maintenance, improvements, and use of enterprise quality management software, including ensuring that defined functions are used throughout Diagnostic Laboratories. Acts as subject matter expert for enterprise quality management software in Diagnostic Laboratories.
• Leads the development of new, and revision of existing SOPs and related controlled documents across the Diagnostic Laboratories including training needs assessments and assignments. Represents Diagnostic Laboratories when collaborating on Versiti level documents and training.
• Key internal and external audit support. Facilitates optimal communication between operations and the inspector/assessors, including implementation of corrective actions to address gaps or findings.
• Leads the development and delivery of training and education in quality management systems, quality and regulatory requirements, and continuous improvement methods and tools to DL.
• Appropriately allocates time and resource when serving on project teams to deliver on deadlines to assists in the achievement of Diagnostic Laboratories goals and objectives in support of the vision and mission of Versiti.
• 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

• Bachelor's Degree from an accredited college or university in Clinical Laboratory Science/Medical Technology (MLS/CLS/MT) , life sciences, engineering with a science minor, allied health science, business or administration required required

Experience

• 1-3 years of experience as a technical writer, documentation specialist, or writing documents in a standard format required
• 1-3 years Experience in a regulated pharmaceutical, clinical laboratory, or medical environment required
• 4-6 years Experience in a regulated environment where change management, systems integration, and continual process improvement were required and successfully implemented required
• 1-3 years Experience in a role successfully participating in Six Sigma, Lean, or Continuous Improvement required
• 1-3 years Experience in data analysis and making recommendations for process improvement required
• 6+ years of experience working in a transfusion service or immunohematology reference laboratory highly preferred

Knowledge, Skills and Abilities

• Exceptional written, verbal, interpersonal and collaborative team building skills including the ability to communicate technical information to customers at all levels in the organization required
• Proven ability to work independently and with others in an effective manner required
• Knowledge of and ability to apply quality management/process improvement tools including LEAN, root cause analysis, and use of statistics required
• Strong analytical skills and attention to detail required
• Excellent organizational skills with the ability to handle and prioritize multiple tasks and adapt to workflow interruptions and sudden changes in routine work habits required
• Strong computer skills (Word, Excel, Visio, Access Database, Crystal Reports), and the ability to learn and effectively use additional computer software required
• Strong knowledge of regulations and standards related to the laboratory or health care environment, i.e. College of American Pathologists (CAP), Clinical Laboratory Improvement Act (CLIA), Food and Drug Administration (FDA), Association for the Advancement of Blood & Biotherapies (AABB) required
• Strong knowledge of quality systems required

Licenses and Certifications

• Quality Certification, i.e. ASQ CQA, ASQ CQE, etc. within 1 Year preferred
• Lean or six sigma certification within 1 Year desired
• MLS/CLS/MT/BB American Society for Clinical Pathologist (ASCP) certification upon hire preferred
• SBB certification preferred

Tools and Technology

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