Misha Cook
Associate Director Quality Assurance Validation @Rentschler Biopharma
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WORK HISTORY
Associate Director Quality Assurance Validation @Rentschler Biopharma
Milford, MA, US
EDUCATION
Franklin Pierce University
Bachelor of Science (BS), Computer Science
SKILLS
ABOUT MISHA COOK
Experienced with audits and inspections including FDA, EMA, ANVISA (Brazil), Mexico and Japan regulatory agencies. Lead for Autoclave validation program. Designed and implemented bracketing approach for autoclaving load items. Initiated process improvements on autoclave cycles to ensure adherence to regulatory guidelines. Responsible for supervision and project management of direct reports. Assumed lead role for SIP qualification activities for new state-of-the-art mammalian cell culture manufacturing facility. Trained and supervised individuals in all areas of Equipment/Utilities Validation. Performed utilities validation including qualification of water and gas systems, HVAC, cryostorage, Sartorius Freeze-Thaw Cryotrol systems and autoclave IQ/OQ/PQ/ Generate/revise validation protocols and documentation in accordance with cGMP guidelines and validation philosophies. Calibrate, program and maintain validation equipment including Kaye Validator and Valprobes. Execute, review and close out validation protocols for IQ, OQ and PQ testing procedures. Identify and implement process improvements for protocol execution. Perform troubleshooting on CIP and SIP systems. Initiate change controls to revise automated control sequences for CIP and SIP operational improvements. Review and analyze data from executed protocols; write investigation/deviation and summary reports for protocol completion. Implemented QA Validation procedures for validation maintenance in accordance with Q7.
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