Overview:
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:
Operational Excellence Analyst
Help drive quality, compliance, and continuous improvement in a mission-driven healthcare environment.
Versiti is seeking an Operational Excellence Analyst to support our Blood Services operations through process improvement, quality oversight, regulatory compliance, and change management activities. In this role, you'll partner with operational leaders and teams to ensure processes are effective, compliant, and continuously improving while supporting our life-saving mission.
What You'll Do:
- Partner with operational departments to drive process control, continuous improvement, and operational effectiveness.
- Review and improve Standard Operating Procedures (SOPs) to ensure compliance, accuracy, and ease of use.
- Support change management, risk assessments, validations, and process implementation efforts.
- Assist with error management, corrective actions, and investigations.
- Monitor quality metrics, audit findings, proficiency testing results, and compliance activities.
- Participate in internal and external audits and help prepare responses and corrective action plans.
- Evaluate product and unit disposition related to investigations and operational events.
- Serve as a resource for regulatory, quality, and procedural requirements.
- Support system enhancements, electronic documentation processes, and database change requests.
- Collaborate with cross-functional teams to identify opportunities for operational excellence and process improvement.
What We're Looking For:
- Experience working in a regulated environment with a strong focus on quality, compliance, and process control.
- Knowledge of change management, validation activities, and SOP development.
- Strong analytical, organizational, and problem-solving skills.
- Ability to collaborate effectively with operational leaders and frontline teams.
- Comfortable managing multiple priorities while maintaining attention to detail.
Education & Experience:
Required
- High School Diploma or equivalent.
- 1+ years of experience in a regulated industry supporting quality, compliance, change management, validation, or process improvement activities.
Preferred
- Bachelor's degree in a scientific field or other discipline related to healthcare, manufacturing, or quality systems.
- Experience in a cGMP, ISO-certified, manufacturing, healthcare, laboratory, blood banking, or other regulated environment.
Why Versiti?
At Versiti, every role contributes to saving lives and advancing patient care. Join a team dedicated to quality, innovation, and continuous improvement while making a meaningful impact on the communities we serve.
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 review departmental SOPs for correctness, ease of use and compliance with regulations, policies, and pertinent quality performance standards and expectations.
- Assists risk assessment with change and error management
- Consults with operational units to oversee efficient change control and validation processes.
- Works directly with the operational units to collect, organize, monitor, and distribute information related to the quality functions within the departments.
- Oversees and assists departments with tracking audits, proficiency testing results, and error management documentation. Makes recommendations for improvements, corrective or preventative actions and responses to audits/surveys.
- Determines product suitability resulting from incident management events.
- Supports corrective action with change and error management
- Participates in system design and implementation to ensure process control
- Participates in external and internal audits.
- Serves as a resource person for procedural and regulatory issues for the department
- Supports and evaluates unit/product disposition associated with errors and investigations
- 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.
- Participate and/or support training associated with activities such as validations and test cases.
- Addresses errors associated with electronic documentation and facilitates request for database, configurations and other system changes.
- 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
Qualifications:
Education
- High School Diploma or equivalent required
- Bachelor's Degree in science or field related to blood center activities preferred
Experience
- 1-3 years technical or consultant 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
Knowledge, Skills and Abilities
- Strong organizational skills with excellent verbal and written communication skills required
- Ability to functionally apply federal, state, and accrediting agency regulations to departmental processes. preferred
- Proven ability to recognize and enforce compliance to SOPs (standard operating procedures) required
- Strong facilitation skills preferred
- Capability to learn, apply and facilitate root cause analysis preferred
- Strong critical thinking and problem-solving skills preferred
- Skilled in coaching to improve performance and achieve departmental goals preferred
- Working knowledge of quality business processes such as current Good Manufacturing Practices (cGMPs) and Continuous Improvement (CI) preferred
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