Improver

Alexander Cyr

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.

Skills:
● 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.

Email: cyrbot99@gmail.com
610-955-7814

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Experience:

• Quality Assurance/Quality Control Microbiologist (Pentec Health)
• Manufacturing Associate (Fibrocell Science)
• Technical Operations Assistant (Merck)
• Scientific Process Associate (Janssen Inc.)
• Quality Control Associate (Fibrocell Science)
• Technical Operations Associate (Merck)
• QA Auditor (Charles River Laboratories)

Skills: