Analyst Operational Excellence

Versiti, Inc. is hiring an Operational Excellence Analyst to support Blood Services operations. The role focuses on quality oversight, regulatory compliance, process control, change management, and continuous improvement.

What you'll do:

• 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

What they're looking for:

• High School Diploma or equivalent
• 1+ years of experience in a regulated industry supporting quality, compliance, change management, validation, or process improvement activities
• High School Diploma or equivalent required
• 1-3 years technical or consultant experience in a regulated industry where change management, validation and creation of SOPs (standard operation procedures) required
• Strong organizational skills with excellent verbal and written communication skills required
• Proven ability to recognize and enforce compliance to SOPs (standard operating procedures) 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
• 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
• Bachelor's Degree in science or field related to blood center activities preferred

Benefits:

• Full-time regular employees are eligible for Medical, Dental, and Vision Plans
• Full-time regular employees are eligible for Paid Time Off (PTO) and Holidays
• Full-time regular employees are eligible for Short- and Long-term disability
• Full-time regular employees are eligible for life insurance
• Full-time regular employees are eligible for a 7% match dollar for dollar 401(k)
• Full-time regular employees are eligible for voluntary programs
• Full-time regular employees are eligible for discount programs