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 support to the Quality department in the area(s) of quality, compliance and/or regulatory affairs. 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 partners with service lines to provide quality input on projects and everyday tasks.

Responsibilities

• Core Quality Assurance Specialist Responsibilities * Supports Supervisor/Manager in executing the Quality Plan and ensuring compliance with applicable regulations and standards. * Identify and develop quality system improvements. * May integrate continuous improvement practices adopted by Versiti into quality systems, education, and improvement activities. * May support internal/external assessments as assigned and facilitates optimal communication between the department and the inspector/assessors. * Prepares charts, tables, etc. to analyze quality metrics. May communicate results and actions of quality metrics. * May review, approve and/or execute validation plans, corrective action plans associated with events, and other required documents for compliance as required. * Supports operations with review of proposed changes in methods, manufacturing, or instrumentation. * May support with the development, compilation, and submission of regulatory submissions as required. * Review, analyze, approve, and monitor events logged in event management system, including adequacy of investigation, quality of documentation, and appropriateness of corrective and preventative actions. * May support Manager with the review of events to assess impact to products/test results. * Acts a resource for regulatory and quality matters.
• Specific Quality Assurance Specialist Responsibilities * Identify emerging events in the applicable service line(s) and assess product, donor, patient, and/or customer impact and risk. * Conduct problem surveillance (event reports, audit deficiencies, customer complaints, supplier recalls, etc.) and work with customers to effectively resolve problems. * Perform review of nonconforming products. Participate in decisions to determine product suitability for use, distribution, or recall. * Support organizational projects from a quality perspective and complete assigned tasks in a timely manner. * Ensure applicable service lines comply with the requirements of the quality management system, as applicable. * Serve as back up support to other Quality Assurance Specialists. * Actively participate in training, continuous improvement activities and Lean initiatives. * Perform other duties as assigned by direct supervisor or Quality leadership.
• Performs other duties as assigned
• Complies with all policies and standards

Qualifications

Education

• Bachelor's Degree (in Clinical Laboratory Science, life sciences, engineering with science minor, scientific discipline, or allied health science discipline) required
• Associate's Degree (in Clinical Laboratory Science, life sciences, engineering with science minor, scientific discipline, or allied health science discipline) required

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
• Experience in QMS, QA, QC, or Quality Auditing preferably in an environment such as blood banking, pharmaceutical, medical devices, or a hospital preferred

Knowledge, Skills and Abilities

• Understands and applies the principles and practices in a recognized professional field requiring extensive academic preparation and experience
• Likely to be an experienced professional qualified in a specific field, or may have experience in a complex technical area
• Determines and implements a course of action based on guidelines and may modify processes and methods as required
• Generally, requires knowledge of company policies, practices, and procedures
• Ability to read and interpret applicable regulations and standards required
• Knowledge and application of external standards and regulations preferred
• Ability to use professional concepts and company's policies and procedures to solve a variety of problems works on problems of moderate scope required
• Strong communication and business acumen skills required
• Proficiency in Microsoft Office
• Possess strong attention to detail
• Knowledge of GxP requirements such as Good Documentation Practice (GDP) and FDA Quality System Regulations (QSR) required

Licenses and Certifications

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