Senior Operational Support Analyst

About the role

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.

Responsibilities

• 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 primary 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.
• Prepare and present project status and special reports as needed.
• Monitor the effectiveness of changes and corrective actions; coordinate follow-up and participate in system design and implementation to ensure process control.
• Serve as a resource for procedural and regulatory issues for the department.
• Support lot release functions and review operational records on a daily, monthly, and quarterly basis as needed.
• Maintain up-to-date knowledge of quality issues through participation in meetings, task forces, committees, and self-directed learning.
• Uphold and reinforce Versiti customer service standards.
• Comply with all policies and standards.

Requirements

Education

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

Experience

• 4–6 years of technical, quality, operational, consulting, or leadership experience in a regulated environment where change management, validation, and creation of SOPs are required.
• Experience with SOP development, process improvement, change management, validation, and regulatory compliance.
• Demonstrated ability to lead cross-functional initiatives and influence process improvements.
• Manufacturing experience in a cGMP, ISO-certified, or equivalent certified environment preferred.
• Experience in blood banking, healthcare, laboratory, manufacturing, pharmaceutical, biotechnology, or other regulated industries preferred.
• Experience working in cGMP, ISO-certified, FDA-regulated, AABB, or similarly regulated environments preferred.
• Experience facilitating root cause investigations, risk assessments