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QA Systems Compliance Specialist
Location:
Abee
Description:
About the role Location: Carlsbad, CA About the Role: This position is a member of the Quality department and has direct responsibility for Quality review and release of systems (software, equipment, instrumentation, utilities) used at Navigate in support of Gx P functions including IVD and CLIA activities. The position provides Quality oversight and approval in partnership with business functions ensuring systems are appropriately qualified and validated for intended use and supporting the lifecycle of systems (onboarding, maintenance, change, periodic review, and retirement). The position requires an associate who can present Navigate's compliance program along with executed project documents and records during external inspections/audits. The position will support continuous improvement through the development of training, guidance documents and templates. ESSENTIAL DUTIES AND RESPONSIBILITIES: • Responsible for systems compliance to US Gx P and EU regulations for Gx P, IVD, and CLIA activities• Responsible for computer system validations (CSV) along with lab equipment systems to ensure compliance with Gx P and CLIA• Provide input for the design, implementation and validation of new systems or change to existing• Provide Quality oversight, review, and approval for regulated systems including validation, maintenance, change control, and incident records• Review and approve records for regulated systems• Prepare and maintain site audit readiness and present process and records during regulatory and sponsor inspections• Represent Quality in IVD Design Control activities and product release• As a member of the Quality Department, support other departmental activities as assigned. • Work in a Gx P/CLIA regulated environment and is responsible for following all applicable regulations ADDITIONAL RESPONSIBILITIES: • Ensuring that Quality Events such as incidents and deviations are proper documented, and for supporting/owning the immediate remediation. Visit ListedBuy for more information.
Company:
Novartis
Posted:
January 27 on ListedBuy
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