Connie y Chan
Senior Project Manager, Amgen; PMP, ASQ-CQA, Project Management, Quality Assurance, Risk Management, Compliance, Pharma, Medical Device, MDR
- Role
- Senior Global Program Manager at Amgen
- Location
- Los Angeles, CA, US
- LinkedIn followers
- 500 followers
About Connie y Chan
Project management professional with a solid background in the biotech/BioLogics/medical device industries. Extensive experience in multiple disciplines: R&D, process development, quality compliance and project management. Specialized in:Project management for biologics/device companies Quality system remediationsAudits and audit findings closure (Certified Quality Auditor by ASQ)Training material generationQuality documentation review and generation
Experience
Senior Global Program Manager
Aug 2021 — Present
Education
Waldorf College
AA, Biology
1992 — 1994
Hamline University
BA, Biology
1994 — 1996
University of Southern California
MS, Biochemistry and Molecular Biology
1996 — 2000
Skills
- Quality Assurance
- Glp
- Usp
- U.s. Food and Drug Administration (Fda)
- Complaint Investigations
- Design History
- Protein Expression
- Project Coordination
- Corrective Actions
- Design Control
- Compliance
- Sop Development
- Investigation
- Molecular Cloning
- Validation
- Experimental Design
- Medical Devices
- Analytical Skills
- Document Drafting
- Rt-Pcr
- Regulatory Requirements
- Document Review
- Pcr
- Process Improvement
- Medical Device Directive
- Real-Time Pcr
- Assay Development
- Change Control
- Study Coordination
- Study Reports
- Trackwise
- Influence Without Authority
- Yellow Belt
- 21 Cfr Part 11
- Project Management
- Regulations
- Study Monitoring
- Root Cause Analysis
- Cell Culture
- Dmaic
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