Analyst Operational Excellence

Versiti, Inc.•Dayton, OH

About The Position

Versiti is seeking an Operational Excellence Analyst to support Blood Services operations through process improvement, quality oversight, regulatory compliance, and change management. The role partners with operational leaders and teams to ensure processes are effective, compliant, and continuously improving in support of Versiti’s life-saving mission. The analyst reviews and improves standard operating procedures, supports change management, risk assessments, validations, investigations, corrective actions, audits, quality monitoring, and product or unit disposition. The position also supports system enhancements and electronic documentation processes, serves as a resource on quality and regulatory requirements, and collaborates across teams to identify and implement opportunities for operational excellence.

Requirements

High school diploma or equivalent.
At least 1 year of experience in a regulated industry supporting quality, compliance, change management, validation, or process improvement activities; the qualifications section specifies 1–3 years of technical or consultant experience.
Experience with change management, validation, and creation of standard operating procedures.
Strong organizational skills and excellent verbal and written communication skills.
Ability to recognize and enforce compliance with SOPs.
Ability to apply federal, state, and accrediting agency regulations to departmental processes is listed as preferred in the qualifications section.
Strong analytical, critical-thinking, problem-solving, and attention-to-detail skills.
Ability to collaborate with operational leaders and frontline teams and manage multiple priorities.
Required ability to use a personal computer and general office equipment.
Required computer software skills, including word processing, spreadsheets, databases, and statistical analysis tools.

Nice To Haves

Bachelor’s degree in a scientific field or a discipline related to healthcare, manufacturing, blood center activities, or quality systems.
Experience in a cGMP, ISO-certified, manufacturing, healthcare, laboratory, blood banking, or other regulated environment.
Strong facilitation skills.
Ability to learn, apply, and facilitate root cause analysis.
Skill in coaching to improve performance and achieve departmental goals.
Working knowledge of quality business processes such as current Good Manufacturing Practices (cGMPs) and Continuous Improvement (CI).

Responsibilities

Partner with operational departments to advance process control, continuous improvement, and operational effectiveness.
Review departmental SOPs for correctness, compliance, performance standards, and ease of use; recommend improvements.
Assist with risk assessments, change management, error management, corrective actions, and investigations.
Consult with operational units on change control and validation processes.
Collect, organize, monitor, and distribute information related to departmental quality functions.
Track audits, proficiency testing results, and error management documentation; recommend corrective or preventative actions and responses to audits and surveys.
Determine product suitability and support unit or product disposition associated with incidents, errors, 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.
Serve as a resource for procedural, regulatory, quality, and compliance requirements.
Participate in system design and implementation to ensure process control.
Support system enhancements, electronic documentation, and database, configuration, and other system change requests.
Participate in or support training related to validations and test cases.
Maintain current knowledge of quality issues through meetings, task forces, committees, and self-directed learning.
Work toward departmental goals and objectives in support of Versiti’s vision and mission, and comply with applicable regulations, policies, and procedures.
Perform other duties reasonably within the scope of the job classification.