Location: United States Job Identification: 1309 Job Schedule: Full time
Myriad Genetics is currently seeking a full time Quality Assurance Manager to join our Clinical Research team! This position does have the ability to be Remote/Work From Home.
Representing Quality Assurance team in development projects, supporting development team in international regulatory compliance
Maintenance and development of the Quality management system, quality policy, quality goals, support management review process
Preparation of internal and external audits
Supply chain management and quality assurance agreements
Documentation of change process within Quality management processes, corrective actions, preventive actions
Support in writing technical documentation for regulatory submissions according to IVDD/IVDR or international standards as required
Support in obtaining and maintaining market access for all products /countries
Deputy safety officer, support in complaints management
Training support and documentation
Scientific or technical education, master or diploma or equivalent, PhD advantageous but not essential
At least 2 years QA or QC or RA in IVD or medical device or pharmaceutical company
English language business proficient
Molecular biology method training and hands-on experience
Preferred experience in RT-PCR
Preferred experience with IVD- or assay development experience
Detail oriented, reliable, diligent
Interested to work in an international, cross-functional team
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.
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.