Lauren Smith Email & Phone Number
Chief Quality Officer, EVP Manufacturing and CMC @ Orca Biosystems
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Lauren Smith Location
- Massillon, OH, US
Lauren Smith Work
- Chief Quality Officer, EVP Manufacturing and CMC @ (March 2025 - Present)
- Chief Quality Officer @ (April 2023 - March 2025)
- Board Member @ (January 2022 - Present)
- Vice President @ (October 2020 - June 2023)
- Senior Director Quality and Site Quality Head @ (March 2018 - October 2020)
- Director of Quality Assurance and Validation @ (October 2017 - August 2018)
- Validation Director @ (October 2013 - October 2017)
- Associate Director, Validation @ (April 2010 - December 2013)
- Supervisor, Microbiology @ (October 2008 - April 2010)
- Senior Microbiologist @ (September 2007 - October 2008)
- Technical Writer @ (August 2006 - September 2007)
- Monitoring Technician @ (June 2005 - August 2006)
Lauren Smith Education
- The University of Akron
MS Biology (Microbiology, Ecology, Evolutionary Biology, Genetics)
2003-2005 - The University of Akron
BS Biology (Biology)
2000-2003
Lauren Smith Skills
- 21 CFR Part 11
- Aseptic Processing
- CAPA
- Change Control
- Corrective and Preventive Action (CAPA)
- Endotoxin evaluation (Gel clot method, kinetic-chromogentic method)
- Excel
- FDA
- GMP
- ISO
- Investigations
- Microbiology
- Microsoft Office
- Pharmaceutical Industry
- Pharmaceuticals
- Problem Solving
- Process Validation
- Quality Control
- Quality System
- Risk Assessment
- SOP
- Standard Operating Procedure (SOP)
- Supervisory Skills
- Technical Writing
- Troubleshooting
- V&V
- Validation
- cGMP
- media fill simulations, process validation, container closure evaluation
- method development and validation
- microorganism identification (genetic, biochemical and phenotypic methods)
- sterility testing, bioburden testing, particulate testing (HIAC)
- 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
- Media Fill Simulations
- Container Closure Evaluation
- Corrective And Preventive Action Capa
- Standard Operating Procedure Sop
- 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 Orca Bio, AxessPointe Community Health Centers 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 21 CFR Part 11, Aseptic Processing, CAPA, Change Control, Corrective and Preventive Action (CAPA) and more. Lauren Smith has 2 emails and 2 mobile phone numbers on RocketReach.
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