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Form of workLocation: San Francisco, California
The Quality Assurance Auditor supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established Quality Assurance processes and standards for company products, services and processes. Role performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Role is responsible for identifying risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them. Role facilitates internal training on Quality Assurance requirements, processes, and procedures. May perform audits and risk assessments.
Duties and Responsibilities:
Provide internal audit services in compliance with the Corporate Audit Program and Invitae Quality System.
Coordinate, maintain and publish the Audit schedule.
Conduct internal audits of Clinical Operations.
Ensure that the Internal Audit program is effective in assessing the health of the Clinical Laboratory Quality Management System.
Collaborate with Quality, Regulatory and Laboratory leaders to ensure ongoing audit readiness of the site.
Work with team leads to ensure findings are addressed in a timely fashion and meet regulatory compliance.
Provide Audit KPIs as part of Quality Management Review.
Work cross-functionally to lead and provide the necessary support for external audits. This includes regulatory, client and vendor audits.
Support quality improvement initiatives and other Quality System activities, as assigned.
Minimum Qualifications:
Bachelor's degree in scientific discipline (required).
12+ years' work experience in the biologics industry, preferably in a laboratory setting.
Experience working in a regulated clinical laboratory (CLIA /CAP/ FDA / ISO).
Audit Certification (preferred)
Experience hosting inspections from a regulatory agency (required).
Experience conducting audits (internal or external 3rd party).
Strong communication skills and ability to effectively communicate with people of all levels.
Ability to interpret policies, procedures, and regulatory requirements.
Ability to make decisions impacting product and sample safety based on independent judgment and discretion.
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