Roblie Vergara
Quality Systems Specialist III
- Role
- Quality Systems Specialist Iii at Gilead Sciences
- Location
- San Jose, CA, US
- LinkedIn followers
- 500 followers
About Roblie Vergara
I have a B.S. in Bioengineering from the University of California, Berkeley, and over 10 years of experience in the biotech/biopharmaceutical industry.My core competencies include GMP, drug substance operations, project management, change controls, CAPA, NPI, batch records, and commissioning/qualification/validation. In my most recent role, I oversaw capital expenditure projects and manufactured marketed Botox drug substance, following the highest standards of quality and safety per FDA and CDC guidelines. I have successfully managed and executed multiple projects to improve the equipment, procedures, and systems in the manufacturing facility, earning recognition from Managers and Associate Directors. I have also led cross-functional teams to produce high-quality GMP drug substance, collaborating with internal and external stakeholders. My mission is to contribute to the development and delivery of innovative and life-changing therapies for patients.
Experience
Quality Systems Specialist Iii
Jun 2024 — Present · Foster City, CA, US
Investigation Core Team (ICT)
Education
University of California, Berkeley
B.S., Bioengineering
2008 — 2012
Skills
- Batch Record Review
- Corrective and Preventive Action (Capa)
- Good Manufacturing Practices
- Customer Service
- Organic Chemistry
- Chemistry
- Crystal Reports
- Root Cause Analysis
- Management
- Biotechnology
- C++
- Java
- Microsoft Office
- Trackwise
- High-Performance Liquid Chromatography (Hplc)
- Quality Control
- Testing
- Photoshop
- Capillary Electrophoresis
- 5s Methodology
- Business Intelligence
- Microsoft Word
- Research
- Visual Basic
- Continuous Process Improvement
- Good Documentation Practices
- Laboratory Information Management System (Lims)
- Kaizen
- Oracle Agile Plm
- Validation
- Powerpoint
- Microsoft Excel
- Liquid Chromatography-Mass Spectrometry (Lc-Ms)
- Sql
- Standard Operating Procedure (Sop)
- Oligonucleotide Synthesis
- Lean Manufacturing
- Public Speaking
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