Sr QA Specialist

About the Job

The Senior Specialist, Quality Assurance Laboratory Operations leverages skill in efficient, regulation-adherent processes, assessments, and process improvements to further improve quality functions, formalized procedures, operations, and systems. The Senior Specialist is responsible, in order of business priority, for inspections, monitoring, auditing, revising quality standards per regulation and business procedural changes, and making recommendations to improve the quality of processes and products. The Senior Specialist ensures continued compliance with CLIA, NYS DOH, and other applicable regulations.

Key Responsibilities

• 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), College of American Pathologists (CAP), and the FDA.
• Review and approve the information to ensure it meets Foundation Medicine standards and procedures and is clearly and appropriately justified as applicable, including but not limited to :

Non-Conformance reports;

Clinical Laboratory Improvement Amendments of 1988 (CLIA);

Qualifications :

Basic Qualifications :

Preferred Qualifications :

The expected salary range for this position based on the primary location of Morrisville, NC is $96,240 - $120,300 per year. The salary range is commensurate with Foundation Medicine’s compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.

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