Mitchell Wirka Email & Phone Number
VP of Quality and Regulatory @ Microbiologics
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Mitchell Wirka Location
- Elk River, MN, US
Mitchell Wirka Work
- VP of Quality and Regulatory @ (June 2022 - Present)
- Sr. Director of Quality Systems @ (July 2019 - October 2021)
- Director of Quality @ (July 2017 - July 2019)
- Director of Quality @ (August 2016 - July 2017)
- Quality Systems Manager @ (October 2013 - August 2016)
- Sr Quality Engineer @ (January 2011 - October 2013)
- Quality Engineer II @ (March 2010 - January 2011)
- Quality Assurance Associate III @ Genmab MN, Inc (Formerly PDL BioPharma) (July 2005 - January 2010)
- Quality Assurance Line Auditor @ CIMA Labs (October 2003 - July 2005)
Mitchell Wirka Education
- University of Minnesota Morris
BA, BA, Minor (Chemistry, Biology, Computer Science)
1997-2003
Mitchell Wirka Skills
- V&V
- Quality System
- 21 CFR Part 11
- FDA
- Validation
- Root Cause Analysis
- Quality Auditing
- Quality Assurance
- CAPA
- GMP
- SPC
- Quality Control
- ISO
- Minitab
- Clinical Trials
- Training
- European Union
- Technology Transfer
- Design Control
- Change Control
- DMAIC
- Medical Devices
- FMEA
- Supplier Quality
- Regulatory Requirements
- Six Sigma
- Computer System Validation
- Design of Experiments
- R&D
- Auditing
- Continuous Improvement
- Manufacturing
- Product Development
- Pharmaceutics
- ISO 13485
- Biotechnology
- ISO 14971
- Integration
- Cross-functional Team Leadership
- 21 CFR
- Bloodborne Pathogens
- Curiosity
- GxP
- Process Improvement
- U.S. Food and Drug Administration (FDA)
Mitchell Wirka Summary
- Mitchell Wirka, based in Elk River, MN, US, is currently a VP of Quality and Regulatory at Microbiologics, Inc.. Mitchell Wirka brings experience from previous roles at Cantel Medical, CHF Solutions, Inc. and Cardiovascular Systems, Inc.. Mitchell Wirka holds a 1997 - 2003 BA, BA, Minor in Chemistry, Biology, Computer Science @ University of Minnesota Morris. With a robust skill set that includes V&V, Quality System, 21 CFR Part 11, FDA, Validation and more. Mitchell Wirka has 3 emails and 2 mobile phone numbers on RocketReach.
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Others Named Mitchell Wirka
Mitchell Wirka
VP of Quality and Regulatory
Elk River, MN, US
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