30 días de edad

Quality Assurance Specialist

Myriad Genetics, Inc
Austin, TX 78701
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  • código de trabajo
    144349682
Location: Austin, TX, United States
Job Identification: 1549
Job Schedule: Full time

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

Qualifications
  • Bachelor's degree (preferably in clinical laboratory science, healthcare or other related field).
  • A minimum of 2 years relevant experience including experience working with the FDA Quality System Regulations.
  • ASCP Medical Laboratory Scientist (MLS) with FDA experience is highly preferred.
  • 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.
  • Strong research, analytical, and problem solving skills.
  • Ability to set priorities and adapt to changing business needs and manage multiple projects within established time frames.
  • Excellent interpersonal and relationship skills; ability to build and develop business relationships with customers and business partners.
  • Ability to clearly and effectively communicate complex issues and concepts orally and in writing.
  • Ability to effectively and confidentially advise and interact with Myriad executives, department directors and managers, staff, and external organizations and agencies.

Physical and Mental Job Requirements
  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
  • While performing the duties of this job, the employee is frequently required to sit; talk; or hear.
  • The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop; kneel; or crouch
  • The employee must occasionally lift and/or move up to 25 pounds.
  • Specific vision abilities required by this job include close vision, distance vision and depth perception.

#LI-KB1

About UsMyriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: maintaining leadership in an expanding hereditary cancer market, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company's website: www.myriad.com .

WE ARE AN EQUAL OPPORTUNITY EMPLOYER. Applicants and employees are considered for positions and are evaluated without regard to mental or physical disability, race, color, religion, gender,national origin, age, genetic information, military or veteran status, sexual orientation, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.

Please answer all questions completely. Please do not provide any information not specifically requested on this Employment Application form.



PI144349682

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Posted: 2021-08-18 Expires: 2021-09-18

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Quality Assurance Specialist

Myriad Genetics, Inc
Austin, TX 78701

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