Senior Analyst Quality & Cont Improv

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 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.

Serves as a 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 with necessary supporting documentation.
• 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 recommends 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.
• Supports 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.
• Supports both internal and external audits as assigned and 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

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Education

• Bachelor's Degree from an accredited college or university in clinical laboratory science, life sciences, engineering with a science minor, allied health science, business or administration 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
• Experience in a role successfully participating in Six Sigma, Lean, or Continuous Improvement required
• Experience in data analysis and making recommendations for process improvement required

Knowledge, Skills and Abilities

• Demonstrated technical writing skills preferred
• Excellent written and verbal communication skills required
• Proven ability to work 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 at one time required
• Ability to adapt to work flow 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

Licenses and Certifications

• Quality Certification, i.e. ASQ CQA, ASQ CQE, etc. within 1 Year preferred
• Lean or six sigma certification within 1-1/2 Yrs desired

Tools and Technology

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