Quality Specialist

Organization
Myriad Genetics, Inc.
Job Location
Salt Lake City, UT 84108
Job Description

Myriad Genetic Laboratories is looking for a Quality Specialist to join our Quality Control team.

Requirements
  1. Monitor organizational practices to verify continuing compliance with regulatory and accreditation programs (CLIA/CAP, NYDSOH, FDA).
  2. Provide regulatory guidance to project teams to ensure that compliance requirements are built into new products or processes prior to implementation.
  3. Oversee the development and continuous improvement of quality programs.
  4. Analyze regulatory information and provide guidance to applicable departments and individuals, as needed.
  5. Evaluate, update, and collaborate on policies, procedures, and training to ensure they reflect current regulatory requirements.
  6. Facilitate the CAPA process to ensure timely completion of action items.
  7. Assist departments in completing investigations to determine root cause of nonconformances and to determine corrective and preventive actions.
  8. Provide support to the customer complaint process – ensure complete investigations and documentation.
  9. Monitor and track quality system data to identify trends and institute corrective and preventive actions.
  10. Occasional technical support of electronic incident management system.
  11. Complete quality reviews for equipment, reagents, procedures and other documents.

1. Bachelor's degree (preferably in clinical laboratory science, healthcare or other related field).

2. A minimum of 5 years relevant experience including experience working with the FDA Quality System Regulations.

3. ASCP Medical Laboratory Scientist (MLS) with FDA experience is highly preferred.

4. Working knowledge of the clinical laboratory and healthcare delivery system as it relates to government agencies and the enforcement of associated federal and state regulations.

5. Strong research, analytical, and problem solving skills.

6. Ability to set priorities and adapt to changing business needs and manage multiple projects within established time frames.

7. Excellent interpersonal and relationship skills; ability to build and develop business relationships with customers and business partners.

8. Ability to clearly and effectively communicate complex issues and concepts orally and in writing.

9. Ability to effectively and confidentially advise and interact with Myriad executives, department directors and managers, staff, and external organizations and agencies.

How to Apply

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