Senior Operational Support Analyst

Versiti Blood Center of Ohio; Wisconsin; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical, Dental, Vision plans

PTO and Holidays

7% 401(k) match

Discount programs

Job summary

Versiti seeks a Senior Operational Support Analyst to advise operational leaders on quality systems, process improvement, change management, regulatory compliance, and operational effectiveness. You will analyze complex processes and drive cross-functional initiatives in a highly regulated environment.

The role involves SOP development, risk assessments, audits, training, and leading projects that improve operations and patient safety across the organization.

Qualifications

• Bachelor's degree in science or related to blood center activities is 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.

Responsibilities

• Develop, review, and improve SOPs to ensure regulatory compliance and operational effectiveness.
• Lead risk assessments, RCA, FMEA, process mapping, and other improvements.
• Consult with teams on change control, validation, and implementation of improvements.
• Create quality indicators, reporting tools and metrics to monitor risks.
• Support incident management, CAPA, investigations, and effectiveness monitoring.
• Coordinate audits, proficiency testing, and quality-related activities.
• Lead organization-wide process and operational improvement projects.
• Assess product suitability after incidents or deviations.

Skills

SOP development

Process improvement

Change management

Regulatory compliance

Cross-functional leadership

Audits and CAPA

Education

Bachelor's in science or related field

High School Diploma

Tools

Word processing software

Spreadsheets (Excel)

Databases

Statistical analysis tools

Job description

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.

Position Summary

Senior Operational Support Analyst

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.

What You'll Do

• 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.

What You'll Bring

Required Education

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

Required Experience

• 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.

Preferred Qualifications

• 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.

Why You'll Love This Role

• 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.

Total Rewards Package

Compensation

The target salary is based on internal averages. Versiti sets salary ranges aligned to local markets in which the job is performed. Compensation decisions take into account internal salary averages and differentiation based on education, experience, skills, and performance. Specific salary and benefits information is shared at the time of the phone screening based on your location and qualifications.

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.

Responsibilities

• Works with departmental staff/management to develop and/or review departmental SOPs for correctness, ease of use and compliance with regulations, policies, and pertinent quality performance standards and expectations.
• Performs impact analysis, risk assessments and facilitates process analysis and change with operational departments. Utilizes and teaches use of related tools such as flowcharts, FMEA, cause and effect diagrams, RCA, etc.
• Consults with operational leadership to lead and oversee efficient change control and validation processes.
• Develops tools and identifies quality indicators to report information related to quality process/function risks within the departments.
• Develops, oversees and assists departments with tracking audits, proficiency testing results, and incident management documentation. Partners with operations to determine necessary corrective and preventative actions.
• Leads projects at Versiti level for organizational changes.
• Prepares and presents project status and special reports as needed.
• Performs impact assessment and determines product suitability resulting from incident management events.
• Monitors the effectiveness of changes and corrective actions; coordinates follow-up and participates in system design and implementation to ensure process control.
• Serves as a resource person for procedural and regulatory issues for the department.
• Participates in external and internal audits.
• Supports lot release functions and reviews operational records on a daily, monthly, and quarterly basis as needed.
• Primary lead for research protocols associated with collecting and testing of blood products.
• Using Versiti core values, works toward achievement of departmental goals and objectives in support of Versiti’s vision and mission.
• Maintains up-to-date knowledge of quality issues through participation in meetings, task forces, committees and self-directed learning.
• Upholds and reinforces the customer service standards of Versiti.
• Participates in creation and delivery of training on a process level.
• Acts as a partner with the other members of the departments to provide services to customers.
• Performs other duties as assigned.
• Performs other duties as assigned
• Complies with all policies and standards

Qualifications

Education

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

Experience

• 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

Knowledge, Skills And Abilities

• 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

Tools and Technology

• 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