Senior Operational Support Analyst

Versiti, Inc.•Dayton, OH

About The Position

Versiti is seeking a Senior Operational Support Analyst to advise operational leaders on quality systems, process improvement, change management, regulatory compliance, and operational effectiveness in a highly regulated environment. The role analyzes complex processes, leads cross-functional initiatives, and helps improve operations that support safe, high-quality blood products and services. The analyst works with departments to develop and review SOPs, facilitate risk and impact analyses, and guide change control and validation. The role supports incident investigations and corrective actions, coordinates audits and proficiency testing, develops quality indicators and reporting tools, and monitors whether changes are effective. The position also leads organization-wide improvement projects, evaluates product suitability following incidents, participates in audits and regulatory readiness, and serves as the primary lead for research protocols related to collecting and testing blood products. The position includes preparing project reports, supporting lot-release functions and operational-record reviews as needed, advising on procedural and regulatory issues, and creating and delivering training. The analyst collaborates with operational, scientific, and quality colleagues and contributes to Versiti’s goals, customer service standards, and mission.

Requirements

Bachelor’s degree in science or a field related to blood center activities.
High school diploma or equivalent.
Four or more years of technical, quality, operational, consulting, or leadership experience in a regulated environment; the qualifications section specifies 4–6 years of technical, consultant, or managerial experience.
Experience with change management, validation, and developing SOPs in a regulated industry.
Experience with SOP development, process improvement, and regulatory compliance.
Ability to lead cross-functional initiatives and influence process improvements.
Strong organizational skills and excellent verbal and written communication skills across all levels of leadership.
Ability to interpret and apply federal, state, and accrediting-agency regulations and assess direct and indirect impacts across functions.
Ability to apply continuous-improvement principles and tools to analyze and improve Blood Services processes.
Strong analytical, critical-thinking, and complex problem-solving skills.
Leadership, mentoring, and coaching skills.
Knowledge of adult-learning principles and effective training techniques.
Ability to write technical information clearly and concisely.
Ability to ensure SOPs meet regulatory, policy, and quality-performance expectations.
Ability to facilitate large, diverse teams across the organization.
Knowledge of quality business processes, including current Good Manufacturing Practices and continuous improvement.
Ability to use a personal computer and general office equipment.
Ability to use word-processing, spreadsheet, database, and statistical-analysis software.

Nice To Haves

Experience in blood banking, healthcare, laboratory, manufacturing, pharmaceutical, biotechnology, or another regulated industry.
Experience in a cGMP, ISO-certified, FDA-regulated, AABB, or similarly regulated environment.
Manufacturing experience in a cGMP, ISO-certified, or equivalent environment.
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.

Responsibilities

Work with departmental staff and management to develop and review SOPs for correctness, usability, regulatory compliance, and alignment with quality standards.
Perform impact analyses and risk assessments and facilitate process analysis and change using tools such as flowcharts, FMEA, cause-and-effect diagrams, and root cause analysis.
Consult with operational leadership to lead and oversee change control and validation processes.
Develop tools and identify quality indicators to report process and functional risks.
Coordinate and support audits, proficiency testing, and incident-management documentation; partner with operations to determine corrective and preventive actions.
Lead organizational change and operational improvement projects across Versiti.
Prepare and present project status updates and special reports as needed.
Assess impacts and determine product suitability following incident-management events.
Monitor the effectiveness of changes and corrective actions, coordinate follow-up, and participate in system design and implementation to maintain process control.
Serve as a resource on procedural and regulatory issues.
Participate in internal and external audits and support regulatory readiness.
Support lot-release functions and review operational records on a daily, monthly, or quarterly basis as needed.
Lead research protocols associated with the collection and testing of blood products.
Maintain knowledge of quality issues through meetings, task forces, committees, and self-directed learning.
Create and deliver training related to processes, quality systems, process improvement, and operational changes.
Collaborate with departmental colleagues to provide services to customers and uphold Versiti customer service standards.
Work toward departmental goals and Versiti’s vision and mission, comply with policies and standards, and perform other duties as assigned.