Senior Operational Support Analyst

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.

At Versiti, our mission depends on safe, high-quality processes that support lifesaving blood products and services. As a Senior Operational Support Analyst, you will serve as a trusted advisor to operational leaders, providing expertise in quality systems, process improvement, change management, regulatory compliance, and operational effectiveness. This role is ideal for someone who enjoys analyzing complex processes, leading cross-functional initiatives, and driving meaningful organizational improvements in a highly regulated environment.

• →Partner with operational leaders to develop, review, and improve Standard Operating Procedures (SOPs) to ensure regulatory compliance, usability, and operational effectiveness.
• →Lead process improvement efforts through risk assessments, impact analyses, root cause analysis (RCA), Failure Mode and Effects Analysis (FMEA), process mapping, and other continuous improvement methodologies.
• →Consult with operational teams on change control, validation activities, and implementation of operational improvements.
• →Develop quality indicators, reporting tools, and metrics to identify and monitor process risks.
• →Support incident management activities, including investigations, documentation, corrective actions (CAPA), and effectiveness monitoring.
• →Coordinate and track audits, proficiency testing, and quality-related activities across departments.
• →Lead and support organization-wide process and operational improvement projects.
• →Conduct impact assessments and evaluate product suitability following operational incidents or deviations.

Participate in internal and external audits and support regulatory readiness efforts.

• →Act as the lead for research protocols associated with the collection and testing of blood products.
• →Create and deliver training related to quality systems, process improvements, and operational changes.

• →High School Diploma or equivalent required
• →Bachelor's Degree in science or field related to blood center activities required

• Bachelor’s degree in science or field related to blood center activities required
• High School Diploma or equivalent required.

• 4+ years of technical, quality, operational, consulting, or leadership experience in a regulated environment.
• Experience with SOP development, process improvement, change management, validation, and regulatory compliance.
• Demonstrated ability to lead cross-functional initiatives and influence process improvements.

• Experience in blood banking, healthcare, laboratory, manufacturing, pharmaceutical, biotechnology, or other regulated industries.
• Experience working in cGMP, ISO-certified, FDA-regulated, AABB, or similarly regulated environments.
• Experience facilitating root cause investigations, risk assessments, and CAPA activities.
• Experience developing and delivering technical training materials.
• Knowledge of continuous improvement methodologies and quality tools.

• Make a direct impact on patient care and blood product safety.
• Lead meaningful improvement initiatives that strengthen operations across the organization.
• Collaborate with scientific, operational, and quality leaders.
• Apply analytical, quality, and project leadership skills in a mission-driven environment.

• 4-6 years technical, consultant or managerial experience in a regulated industry where change management, validation and creation of SOPs (standard operation procedures) required
• Manufacturing experience in a cGMP, ISO (International Organization for Standardization), or equivalent certified environment preferred
• Experience in development of technical educational material preferred

• Strong organizational skills with excellent verbal and written communication skills that translate across all levels of Versiti leadership required
• Ability to read, interpret, and functionally apply federal, state, and accrediting agency regulations and determine both direct and indirect impact across functions required
• Expertise and ability to apply principles and tools of continuous improvement to analyze and improve Blood Services processes required
• Proven analytical, critical thinking and complex problem-solving skills required
• Excellent leadership, mentoring and coaching skills required
• Knowledge of the principles of adult learning techniques and effective training abilities required
• Demonstrated ability to write technical information in a clear and concise manner required
• Ability to ensure SOPs (standard operating procedure) are compliant with regulations, policies, and pertinent quality performance expectations required
• Ability to facilitate large, diverse teams across the organization required
• Expertise of quality business processes such as current Good Manufacturing Practices (cGMPs) and Continuous Improvement (CI) required

• Personal Computer (desk top, lap top, tablet) required
• General office equipment (computer, printer, fax, copy machine) required
• Computer software including word processing, spreadsheets, databases, statistical analysis tools required