Analyst Operational Excellence

JOB REQUIREMENTS: 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 ***** APPLICATION INSTRUCTIONS: Apply Online: https://talentwire.org/LgPasG Qualified females, minorities, and special disabled veterans and other veterans are encouraged to apply.