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
- 2022 -now VP of Quality and Regulatory @
- 2019 -2021 Sr. Director of Quality Systems @
- 2017 -2019 Director of Quality @
- 2016 -2017 Director of Quality @
- 2013 -2016 Quality Systems Manager @
- 2011 -2013 Sr Quality Engineer @
- 2010 -2011 Quality Engineer II @
- 2005 -2010 Quality Assurance Associate III @ Genmab MN, Inc (Formerly PDL BioPharma)
- 2003 -2005 Quality Assurance Line Auditor @ CIMA Labs
Mitchell Wirka Education
- University of Minnesota-Morris
BA (BA, Minor, Chemistry, Biology, Computer Science)
1997-2003 - 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 in BA, Minor, 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 2 emails and 2 mobile phone numbers on RocketReach.
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