Jeffrey Rodriguez
- Role
- Senior Specialist- Quality Assurance, at Merck
- Location
- Orlando, FL, US
- LinkedIn followers
- 500 followers
About Jeffrey Rodriguez
I am a leader who enjoys working collaboratively with others. I enjoy being challenged…
Experience
Senior Specialist- Quality Assurance,
Mar 2022 — Present
Sub system owner/ Subject matter expert; Primary for product quality complaints; back up for deviation management. Monitor health of system and develop CAPA to improve system health; Owner of all system procedures and site actions for complaints. • Develop metrics and trends for system health key performance indicators to present to site leadership; Guide manufacturing business units with identified actions to improve system performance. • Provide coaching opportunities and regulatory agency inspection response for topics related to product complaint and deviation management as a SME. • Developed and implemented a global data integrity flow diagram to identify critical data governance failures. • Conduct quality review and approval for investigations related to adverse event. • Generate bi-annual site deviation trend report for key site actions to lower trends, and develop new actions. • Gather and analyze complaint data in support of annual product review for various vaccine products. • Established and implemented a process for controlled substance complaint sample retrieval and updates of quality agreements between Merck sister sites related to biohazard complaint sample. • Created and implemented a tracking and trending site-wide practice for deviation observations.
Education
Rensselaer Polytechnic Institute
Bachelor of Science (B.S.), Chemical Engineering
2006 — 2010
Temple University
Masters of Science in Quality Assurance and Regulatory Affairs
2017 — 2020
Skills
- Product Development
- Continuous Improvement
- Root Cause Analysis
- Process Optimization
- Chemical Engineering
- Process Engineering
- Process Improvement
- Cross-Functional Team Leadership
- R&D
- Fda
- Software Documentation
- Manufacturing
- Quality Control
- Project Management
- Data Analysis
- Troubleshooting
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