media fill simulations, process validation, container closure evaluation
method development and validation
microorganism identification (genetic, biochemical and phenotypic methods)
Validation
Process Validation
Investigations
Microbiology
GMP
Pharmaceuticals
SOP
cGMP
Troubleshooting
CAPA
Excel
Microsoft Office
Problem Solving
ISO
FDA
Technical Writing
Change Control
Risk Assessment
Supervisory Skills
Aseptic Processing
Endotoxin Evaluation Gel Clot Method
Biochemical And Phenotypic Methods
Social Media
Particulate Testing Hiac
Risk Management
Microsoft Excel
Bioburden Testing
Kinetic Chromogentic Method
Sterility Testing
Microorganism Identification Genetic
21 CFR Part 11
Media Fill Simulations
Container Closure Evaluation
Corrective And Preventive Action Capa
Quality System
V&V
Standard Operating Procedure Sop
Quality Control
Pharmaceutical Industry
Microorganism Identification
Corrective and Preventive Action
Endotoxin Evaluation
Standard Operating Procedure
Lauren Smith Summary
Lauren Smith, based in Massillon, OH, US, is currently a Chief Quality Officer, EVP Manufacturing and CMC at Orca Bio. Lauren Smith brings experience from previous roles at AxessPointe Community Health Centers, Orca Bio and Catalent Pharma Solutions. Lauren Smith holds a 2003 - 2005 MS Biology in Microbiology, Ecology, Evolutionary Biology, Genetics @ The University of Akron. With a robust skill set that includes Endotoxin evaluation (Gel clot method, kinetic-chromogentic method), sterility testing, bioburden testing, particulate testing (HIAC), media fill simulations, process validation, container closure evaluation, method development and validation, microorganism identification (genetic, biochemical and phenotypic methods) and more. Lauren Smith has 2 emails and 1 mobile phone numbers on RocketReach.
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