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Sr QA Specialist, Lab Operations
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Full-time
- Foundation Medicine, Inc. (FMI) began with an idea-to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care.
- Assist in all aspects of the full operation, implementation, and maintenance of the Quality Management System (QMS) to ensure continued compliance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA), and the College of American Pathologists (CAP) standards.
- Maintain availability to the wider FMI business to consult and provide guidance on Good Practice (GxP) quality guidelines and specific regulations, including but not limited to: Clinical Laboratory Improvement Amendments of 1988 (CLIA); College of American Pathologists accreditation standards.
- Support FDA, NYS DOH, CAP, and other regulatory agency inspections.
- Alternatively, an associate degree in laboratory science or a related field with 5+ years of experience in a clinical laboratory
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