Mario Gonzalez Email
Senior Quality Engineer @ FITS, LLC
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Mario Gonzalez Location
- Puerto Rico
Mario Gonzalez Work
- Senior Quality Engineer @ (August 2021 - Present)
- M-ERP Validation Lead @ (February 2020 - August 2021)
- Sr Remediation Validation Engineer @ (March 2019 - February 2020)
- Quality System Expert @ (February 2018 - March 2019)
- Computer System Validation Specialist @ Codex Validation Group (CVG) (May 2017 - February 2018)
- Plant Quality Assurance (PQA) and Amgen @ (August 2016 - May 2017)
- System Owner and Amgen @ (November 2015 - June 2016)
- Compliance Engineer @ (May 2015 - November 2015)
- Change Owner and Amgen @ (February 2014 - March 2015)
- Validation Engineer and Novartis @ (January 2014 - February 2014)
- Project Engineer - AME and BARD @ (May 2013 - December 2013)
- CAPA and Investigations Specialist and BMS @ (February 2012 - May 2013)
- Validation Specialist IV @ (December 2006 - January 2012)
- Validation Specialist @ (January 2003 - January 2006)
- Validation Specialist @ (January 2000 - January 2003)
Mario Gonzalez Education
- University of Puerto Rico-Mayaguez
BSME (Mechanical Engineer)
1994-2000
Mario Gonzalez Skills
- 21 CFR
- 21 CFR Part 11
- Analytical Chemistry
- Aseptic Processing
- Biopharmaceuticals
- Biotechnology
- CAPA
- Calibration
- Change Control
- Cleaning Validation
- Computer System Validation
- Contract Manufacturing
- Design Control
- Design of Experiments
- Equipment Qualification
- FDA
- FDA GMP
- FMEA
- GAMP
- GLP
- GMP
- GxP
- HPLC
- ISO
- ISO 13485
- ISO 14971
- LIMS
- Medical Devices
- Minitab
- Pharmaceutical Industry
- Pharmaceutics
- Process Simulation
- Quality Assurance
- Quality Auditing
- Quality Control
- Quality Management
- Quality System
- Regulatory Affairs
- Regulatory Requirements
- Regulatory Submissions
- Root Cause Analysis
- SOP development
- Software Documentation
- Sop
- Sterilization
- Technology Transfer
- Trackwise
- V&V
- Validation
- cGMP practices
Mario Gonzalez Summary
- Mario Gonzalez, based in Puerto Rico, is currently a Senior Quality Engineer at FITS, LLC. Mario Gonzalez brings experience from previous roles at GSK, EG Life Sciences, Business Excellence Consulting, Inc. (PR and Spain Divisions) and Codex Validation Group (CVG). Mario Gonzalez holds a 1994 - 2000 BSME in Mechanical Engineer @ University of Puerto Rico-Mayaguez. With a robust skill set that includes 21 CFR, 21 CFR Part 11, Analytical Chemistry, Aseptic Processing, Biopharmaceuticals and more. Mario Gonzalez has 1 emails on RocketReach.
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