Senior Quality Specialist
We are seeking an experienced and motivated individual to join our team and help build and grow the quality and regulatory organization in a fast-paced, dynamic team environment.
While the Senior Quality Specialist will be responsible for managing existing quality and regulatory activities, other key activities will include leading and managing the development and implementation of new and improved processes and procedures as the company and the Quality organization expands and evolves.
The broad scope and high complexity nature of the work, along with the changing regulatory environment for laboratory developed tests (LDTs), requires meticulous attention to detail, the ability to learn and adapt quickly under pressure, excellent judgment with the ability to analyze complicated issues and the ability to effectively interact and communicate technical and non-technical issues across multiple functions and levels.
Responsibilities:
Provide quality and regulatory guidance and recommendations as needed and assist with troubleshooting of high complexity Clinical Laboratory quality issues
Prepare and analyze quality metrics for Quality Monitoring and Improvement meetings
Develop and analyze quality metrics to monitor and ensure the overall performance of the Clinical Laboratory and identify areas for improvement
Manage nonconformances and deviation approval requests
Review and approve controlled documents and in-process worksheets and forms
Assist with the management of the document control system
Perform internal quality audits, document findings and assist with implementation of corrective and preventive action
Lead preparation of regulatory inspections (CAP, New York)
Prepare, review and submit regulatory license renewals and new product applications
Manage and lead projects in the creation, development and maintenance of Guardant Health's Quality organization
Serve as the Quality and Regulatory representative on cross-functional teams
Manage and/or assist with high complexity Quality and Regulatory projects
Train employees on Quality, Regulatory and other polices and procedures as appropriate to ensure compliance with regulatory requirements
Assist with training, coaching and mentoring junior Quality and Regulatory staff
Perform other duties and responsibilities as assigned
Qualifications:
Bachelor of Arts or Science in Biomedical Laboratory, Clinical Laboratory Science or a related life science
At least seven years of experience in a high-complexity clinical laboratory environment including at least two years in a quality and regulatory role or at least seven years of quality experience
Licensed Clinical Laboratory Scientist or equivalent preferred
Experience with LDTs preferred
Advanced working knowledge of local, state and federal laboratory regulations
FDA submission filing experience preferred
Ability to consistently and clearly communicate effectively across all levels of the organization
Ability to work collaboratively and independently in a team environment
Ability to be pragmatic and balance quality and regulatory compliance with business goals and risks
Willingness to be flexible and wear multiple hats when needed
Possess an entrepreneurial, start-up attitude
Estimated Salary: $20 to $28 per hour based on qualifications.
While the Senior Quality Specialist will be responsible for managing existing quality and regulatory activities, other key activities will include leading and managing the development and implementation of new and improved processes and procedures as the company and the Quality organization expands and evolves.
The broad scope and high complexity nature of the work, along with the changing regulatory environment for laboratory developed tests (LDTs), requires meticulous attention to detail, the ability to learn and adapt quickly under pressure, excellent judgment with the ability to analyze complicated issues and the ability to effectively interact and communicate technical and non-technical issues across multiple functions and levels.
Responsibilities:
Provide quality and regulatory guidance and recommendations as needed and assist with troubleshooting of high complexity Clinical Laboratory quality issues
Prepare and analyze quality metrics for Quality Monitoring and Improvement meetings
Develop and analyze quality metrics to monitor and ensure the overall performance of the Clinical Laboratory and identify areas for improvement
Manage nonconformances and deviation approval requests
Review and approve controlled documents and in-process worksheets and forms
Assist with the management of the document control system
Perform internal quality audits, document findings and assist with implementation of corrective and preventive action
Lead preparation of regulatory inspections (CAP, New York)
Prepare, review and submit regulatory license renewals and new product applications
Manage and lead projects in the creation, development and maintenance of Guardant Health's Quality organization
Serve as the Quality and Regulatory representative on cross-functional teams
Manage and/or assist with high complexity Quality and Regulatory projects
Train employees on Quality, Regulatory and other polices and procedures as appropriate to ensure compliance with regulatory requirements
Assist with training, coaching and mentoring junior Quality and Regulatory staff
Perform other duties and responsibilities as assigned
Qualifications:
Bachelor of Arts or Science in Biomedical Laboratory, Clinical Laboratory Science or a related life science
At least seven years of experience in a high-complexity clinical laboratory environment including at least two years in a quality and regulatory role or at least seven years of quality experience
Licensed Clinical Laboratory Scientist or equivalent preferred
Experience with LDTs preferred
Advanced working knowledge of local, state and federal laboratory regulations
FDA submission filing experience preferred
Ability to consistently and clearly communicate effectively across all levels of the organization
Ability to work collaboratively and independently in a team environment
Ability to be pragmatic and balance quality and regulatory compliance with business goals and risks
Willingness to be flexible and wear multiple hats when needed
Possess an entrepreneurial, start-up attitude
Estimated Salary: $20 to $28 per hour based on qualifications.
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