G. Steven Steve Condrey
Quality Management Analyst at U.S. Food and Drug Administration/Human Foods Program
- Role
- Quality Management Analyst at FDA
- Location
- Omaha, NE, US
- LinkedIn followers
- 500 followers
About G. Steven Steve Condrey
Specialties: quality management, quality engineering, statistics, auditing, technical writing, data science, business analytics
Experience
Quality Management Analyst
Oct 2024 — Present · US
Development of a quality management program within FDA’s new Human Foods Program. Major projects include:*Project Manager for a laboratory optimization and modernization project involving 30 subject matter experts in multiple locations. Current work involves transitioning laboratory analytical packages to paperless format to conform with FDA’s Data Modernization Road Map and ISO 17025 standards * Development of procedures to improve contractor quality assurance in coordination with an experienced Contracting Officer* Creation of Issue Review and CAPA programs * Development of quality metrics for the new program * Evaluation of open-source and SaaS packages for quality data analysis. Currently evaluating Tableau Enterprise for HFP usage* Presenter at FDA Scientific Computing and Digital Transformation Symposium (formerly Scientific Computing Days) in 2024. The presentation discussed the use of quality metrics in evaluating the effectiveness of field operations.* Evaluation of, and staff training for Elsa, FDA\'s internal generative AI
Education
Bellevue University
Master of Professional Studies, Data Science/Data Analytics
2017 — 2018
California State University-Dominguez Hills
Certificate , Quality Engineering
2012 — 2016
Greater Los Angeles Federal Executive Board
Leadership Associates Program
2013 — 2014
Bellevue University
Doctor of Philosophy - PhD, Human Capital Management
2019 — 2023
UC San Diego
Bachelor's, History and Philosophy of Science and Technology
1987 — 1991
Skills
- Legal Writing
- Regulatory Submissions
- Quality Auditing
- Photography
- Risk Management
- Root Cause Analysis
- Quality System
- Quality Systems
- V&V
- Food Security
- Statistics
- Qfd
- Change Control
- Civil Litigation
- Regulatory Requirements
- Copy Editing
- Private Investigations
- Haccp
- Quality Control
- Gmp
- Labor Relations
- R
- Quality Engineering
- Inspection
- Regulatory Affairs
- 21 Cfr Part 11
- Design of Experiments
- Fmeca
- Technical Writing
- Minitab
- Git
- Quality Management
- Github
- Legal Research
- Capa
- Iso
- Sop
- Fda
- Data Mining
- Validation
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