Human Resources Director at Cynerio @ Israel
QA Auditor at Charles River Labs
West Chester, Pennsylvania
I currently have 8+ years of experience in quality roles involved in pharmaceutical production, including cell based therapies and sterile small-molecule injectables. I have worked in both quality control and quality assurance positions within a sterile GMP environment where my responsibilities included managing deviations, SOPs, change controls, protocols, and conducting investigations. I am currently studying with the Temple Regulatory Affairs and Quality Assurance Masters program.
● Investigational Skills (Deviations, CAPAs, Out of Spec Investigations)
● Change Control Management
● Laboratory Environmental Monitoring
● Batch Record Review
● GMP Documentation (SOPs, Protocols, Validation Documents)
● Cell Harvesting and Manufacture
● Quality Control Testing
● Data Trending and Analysis (JMP)
I have performed a variety of tests in support of sterile drug production, including sterility tests, endotoxin tests, environmental monitoring, and bio-burden tests as well as tests in support of cell culturing (cell counts). I also have done oversight as part of quality assurance, including batch record review, deviation investigations, and SOP creation/updating.