| Company: | Myriad Genetics |
| Job Location: |
Salt Lake City - Salt Lake County |
| Employment Type: | Full Time |
Duties: |
This position is responsible for Quality System’s oversight of validation and testing activities. The individual will review and approve validation plans and reports associated with processes and equipment. Additionally, this position will work closely with cross-functional teams and user groups to prepare test cases, design and execute test plans for the validation of systems, applications, hardware components and integration. This is a challenging position that works across all departments and demands a dynamic individual with excellent inter-personal skills.
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Qualifications: |
Minimum Qualifications:
Bachelor’s degree in science/engineering program.
2+ years experience in regulated industry.
Working knowledge of laboratory operations.
Ability to work independently to create and execute test/validation activities.
Must possess strong communication, organization and interpersonal skills.
Must be self-motivated, able to work in a fast-paced environment and work well in an integrated team environment.
Proficient in MS Office. Knowledge and experience in working with relational databases.
Essential Duties and Responsibilities:
Reviews validation documentation to identify product and process related issues, variance and perform needed impact assessments.
Prepares, executes, and documents test/validation protocols and results for equipment, processes and systems.
Coordinates validation tasks with relevant departments and personnel.
Participates in quality improvement project teams as assigned.
Work closely with department management to estimate test effort, required resources and task scheduling to ensure overall project goals are met.
Leads/assists in developing validation strategies and training internal personnel on validation policies/procedures.
Leads/assists in performing exception analysis and resolution.
Preferred Skills:
Statistical background is desired.
Laboratory experience
Working knowledge of compliance and qualification issues (IQ, OQ, and PQ).
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