Regulatory Compliance Coordinator |
| Location: | Salt Lake City, UT |
| Benefits: | Please see benefits link at www.myriad.com/careers |
| Employment Type: | Full Time |
| Department: | Quality - MGL |
| Description: | This position will be a member of the Regulatory Compliance Team that is responsible for administration of the quality assurance and regulatory compliance programs. This position is responsible for coordinating compliance activities within the clinical laboratory. The coordinator works with the Quality and Compliance team to evaluate and oversee the organization's policies and practices to ensure compliance with industry standards and regulations. Knowledge of current regulatory requirements regarding clinical laboratory standards (CLIA/CAP), HIPAA regulations, billing compliance (CMS) along with state regulations (NY, CA) required. The ability to interface with regulatory authorities and accreditation agencies to ensure business practices are in compliance with current industry requirements, and lead negotiations for licenses or other regulatory permissions is desirable. |
| Duties: | Evaluates, oversees and administrates compliance activities within the laboratory to ensure regulatory compliance through procedure reviews, audits and incident reviews
Works with the Regulatory Compliance Team to develop and administer an ongoing compliance program for all laboratory personnel in conjunction with the compliance manager and other departmental liaisons.
Creates, compiles and distributes reports regarding compliance, quality measures and business metrics.
Leads/assists in scheduling and conducting procedural and regulatory compliance audits.
Leads/assists in the administration of proficiency tests for the clinical programs.
Participates in quality improvement project teams to ensure that organizations objectives are met.
Attends meetings on all levels of laboratory administration to provide regulatory guidance as applicable.
Additional duties as assigned.
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| Qualifications: | MT(ASCP) certified individual preferred. BS degree in related scientific discipline would also be considered. Minimum of 2-3 years experience in quality assurance or regulatory environment required. Specific experience in clinical laboratory compliance highly preferred.
Ability to work independently and as part of a team.
Working knowledge of clinical laboratory regulations and compliance standards required.
Working knowledge of computers including MS Office suite and queries preferred.
Excellent teamwork and communication skills.
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