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:

This role provides professional support to the Quality department in the area(s) of quality management system software implementation and administration. This role supports the overall quality program and serves as a liaison between the Quality team and other service lines of Versiti. He/she/they provide quality administration and software support input on the electronic Quality Management System (eQMS) project and other tasks as assigned.

Responsibilities:

Core Quality Responsibilities * Supports Supervisor/Manager in executing the Quality Plan and ensuring compliance with applicable regulations and standards.

* Integrates continuous improvement practices adopted by Versiti into quality systems, education, and improvement activities.

* Identify and develop quality system improvements.

* Prepares charts, tables, etc. to analyze quality metrics. Communicate results and actions of quality metrics.

* May support with the development, compilation, and submission of regulatory submissions as required.

Specific Professional, Quality Management Professional Responsibilities * Supports the maintenance of the electronic Quality Management System for Versiti, including but not limited to document and change management, events management, training, audits, etc.

* Executes implementation and validation plans (including changes and upgrades), corrective action plans associated with electronic Quality Management System (eQMS), and other required documents for compliance of the eQMS as required.

* Administers the eQMS roles and access rights within the eQMS

* Develops and maintains dashboard, reports, and data analytics from the eQMS

* May perform internal audits per the approved Internal Audit Schedule to identify gaps in eQMS software implementation or upgrades

* Reviews, assesses and communicates system performance and trends

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

Associate's Degree (in Information Technology, Engineering, scientific discipline, or allied health science discipline) required

Bachelor's Degree (in Information Technology, Engineering, scientific discipline, or allied health science discipline) preferred

Experience

4-6 years experience required in related field with associate degree required

1-3 years experience required in related field with bachelor's degree required

1-3 years experience in data analytics, data quality, data governance or related experience required

Knowledge, Skills and Abilities

Understands and applies the principles and practices in a recognized professional field requiring extensive academic preparation and experience required

Experienced professional qualified in science and/or technology, or may have experience in a complex technical area required

Ability to use professional concepts and company's policies and procedures to solve a variety of problems works on problems of moderate scope required required

Strong communication, business acumen, and attention to detail skills required required

Works independently to complete assignments and leads by example to guide and develop the database administration process required

Analytical and problem-solving skills with the ability to organize, analyze, and disseminate complex data-related issues and propose effective solutions required

Strong working knowledge of data visualization tools (e.g., Power BI, Tableau) required

Knowledge of GxP requirements such as Good Documentation Practice (GDP) and FDA Quality System Regulations (QSR) required preferred

Licenses and Certifications

Quality certifications (i.e., ASQ CQA, ASQ CQE) preferred

Microsoft Certifications preferred

Tools and Technology

Personal Computer (desktop, laptop, tablet) required

General office equipment (computer, printer, fax, copy machine) required

Microsoft Suite (Word, Excel, PowerPoint) required

electronic Quality Management System software preferred

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