Susan Figert
Director Cmc Regulatory Compliance at Prokidney Corp
Based in Franklin, United States
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Seniority
Director
Department
Science
Location
Franklin
Industry
Biotechnology Research
Company size
213
Contact information
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s•••••••@prokidney.com
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Background
About Susan Figert
Quality Assurance professional experienced in establishing, implementing, and maintaining Quality Systems to ensure compliance with internal and regulatory requirements in a GMP environment. Coach cross-functional personnel in the execution and provide Quality review/approval of activities such as Deviations, Laboratory Investigations, Corrective and Preventive Actions, Change Management, Non-Conforming Material Reports, and Supplier Management records. Drive the implementation of compliant training programs to ensure adequate accountability and capability of personnel and Contract Service Providers based on the scope of the company organizational chart and specific job descriptions and instill an understanding of CFR and ISO requirements. Audit internal processes and policies to identify potential areas of improvement. Experienced at batch record review, document creation and control, and managing projects with cross-functional teams as a Quality representative among all levels of management and entry-level personnel.
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