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A hybrid role at GRAIL.
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Original listing text, shown exactly as published by the company.
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Support clinical laboratory quality operations through competent interpretation and execution of quality engineering principles and concepts in accordance with GRAIL's quality management system and regulatory requirements including ISO 15189, 21 CFR Part 493 (CLIA), CAP, and New York State Department of Health (NYSDOH).
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Leads and contributes to achieve company goals in creative and effective ways.
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Demonstrate technical proficiency, creativity, teamwork, collaboration with others, and regular independent thought.
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Solve moderate problems in which analysis of situations or data requires an in-depth evaluation and assessment of intangible variables.
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Exercise independent judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
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Convey advanced information and persuade several diverse stakeholders/audiences.
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Identify and evaluate deficiencies and improvement opportunities, working cross-functionally to resolve and improve on existing processes.
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Demonstration of increasing technical proficiency; solving moderate problems, with a level of independence in day to day activities.
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Facilitate proficiency testing program/alternative performance assessment program and licensures.
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Facilitate equipment comparability program and CAP checklist completions.
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Support monthly Quality Indices reports and quarterly Quality Monitoring and Improvement (QMI) Reviews.
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Perform risk assessments and work with leadership to create action plans to mitigate laboratory risks.
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Facilitate timely and effective clinical lab-related NCRS, CAPAS, planned deviations, validations, complaints, and change control workflows.
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Serve as SME for clinical laboratory audits and inspections.
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Support maintenance and improvement of the QMS, including ensuring the system is efficient and compliant, through identification and monitoring of key performance indicators. Use professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
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Facilitates Quality Operations-related training, coaching, mentoring and guidance to Clinical Laboratory personnel as well as cross-functional teams.
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BS/BA degree with 3 years of related experience, or Masters with 1 year of related experience, or PhD with related experience within a clinical laboratory (high complexity CLIA/CAP environment) or related (e.g., IVD medical device, pharma, etc.) quality management system.
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Experience working with or working knowledge of applicable regulations and standards including CAP/CLIA, New York State Department of Health, ISO 15189, and other applicable industry requirements.
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Excellent written and verbal communication skills.
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Ability to comprehend and interpret technical information related to analytical methods, processes, and regulatory requirements.
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Master's degree in a related technical area, or MBA.
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Next Generation Sequencing (NGS) experience.
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ASQ Certified Quality Auditor, Certified Quality Engineer, or similar.
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In vitro diagnostic medical device QMS experience (ISO 13485:2016, 21 CFR 820, In Vitro Diagnostic Regulation).
Physical Demands and Work Environment
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Work is performed in office, laboratory, and manufacturing environments.
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Regular interaction with production floor operations for quality reviews and troubleshooting.
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Use of precision measurement and inspection equipment as needed.
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Potential exposure to manufacturing noise, equipment, and regulated materials.
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PPE required when performing inspections or working in controlled environments.
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Standard business schedule with occasional overtime or travel to supplier sites or customer locations.
GRAIL
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GRAIL is a healthcare company dedicated to the early detection of cancer. They develop innovative liquid biopsy technology, including the Galleri test, to identify multiple cancer types from a single blood sample.
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