Location: South San Francisco, CA, United States Job Identification: 883 Job Schedule: Full time
Summary: The Quality Assurance Senior Specialist/Quality Assurance Specialist III is an enthusiastic, self motivated person with great communication skills who can support the inner workings of Myriad Women's Health's quality management systems within a clinical and next generation sequencing laboratory. The Senior Specialist will demonstrate a high level of individual responsibility and accountability and possess the ability to perform the requirements listed below. The candidate will be comfortable in a rapidly evolving Biotech environment, supporting systems based on CLIA, CAP, NYS CLEP, ISO 13485:2016, and FDA QSR regulations.
Essential Job Duties and Responsibilities:
? Design, implement, support, and/or improve any subset of these quality systems:
? Document control
? Non-conformance resolution / CAPA Board
? Equipment qualification and maintenance
? Personnel training
? Internal/external auditing
? Manufacturing batch records
? Management reviews
? Assay Validation
? Product Lifecycle Management
? Supplier Quality Management
? Technology Transfer/Change Control
? Change, Risk Management
? Draft or update corresponding standard operating procedures as per CLIA, CAP, NYS CLEP, ISO13485:2016, FDA 21 CFR 820 requirement needs while utilizing tools such as: JIRA, Confluence, Overleaf (LaTeX), Veeva Vault.
? Design, implement, and monitor quality metrics as they relate to quality management systems to drive areas of improvement.
? Manage, review, verify documentation to ensure they are completed in a timely manner and meets Good Documentation Practices
? Lead continuous improvement project(s).
? Any and all other undefined tasks, as directed by your supervisor. Requirements: ? Minimum, B.S./B.A. in Life Sciences, Chemistry, or Engineering with 4+ years in a quality assurance role or equivalent in a medical device or clinical laboratory environment or equivalent.
? Exceptional attention to detail and organizational abilities a must.
? Experience in a CLIA, CAP, NYS CLEP, ISO 15189, ISO 13485 environment will be viewed favorably.
? Basic understanding of Chemistry and Molecular Biology (as it pertains to DNA sequencing) and Engineering (hardware and software development, understanding) are ideal.
? Knowledge and/or experience with Operations Excellence: Six Sigma, Kaizen, LEAN, 5S, and continuous improvement techniques, etc. is highly preferred.
? Adept with Mac laptops and Microsoft tools.
? Advanced education and ASQ or other quality related certifications will be viewed favorably.
Physical & Lifting Requirements
Lifting Requirements - light work or exerting up to 20 pounds of force frequently.
Use of equipment and tools necessary to perform essential job functions.
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.
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