Professional Quality Assurance

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.

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.

Compensation
The target salary for this position is $80682 annually.

The target salary is based on internal averages. Versiti sets salary ranges aligned to local markets in which the job is performed. Compensation decisions take into account internal salary averages and differentiation based on education experience skills and performance. Specific salary and benefits information is shared at the time of the phone screening based on your location and qualifications.

Benefits
Versiti provides a comprehensive benefits package based on your job classification. Full-time regular employes are eligible for Medical Dental and Vision Plans Paid Time Off (PTO) and Holidays Short- and Long-term disability life insurance 7% match dollar for dollar 401(k) voluntary programs discount programs others.

• 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

Education

• Bachelors Degree (in Clinical Laboratory Science life sciences engineering with science minor scientific discipline or allied health science discipline) required
• Associates 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 bachelors 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 companys 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