Jim Spoo
Staff Engineer Deviations Specialist at Merck
- Role
- Senior Qa Specialist at Merck
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
Information TechnologyView LinkedIn profile
Experience
Senior Qa Specialist
Aug 2013 — Present · Durham, NC, US
Skills
- Microbiology
- Computer System Validation
- Cross-Functional Team Leadership
- Iso 13485
- Quality System
- V&V
- Process Simulation
- Design of Experiments
- Quality Assurance
- Cleaning Validation
- Lims
- Pharmaceutical Industry
- Sop
- Fda
- Root Cause Analysis
- Quality Control
- Gmp
- Validation
- Chromatography
- 21 Cfr Part 11
- Technology Transfer
- Biotechnology
- Design Control
- Six Sigma
- Gxp
- Quality Auditing
- Aseptic Processing
- Commercialization
- Change Control
- Trackwise
- Biopharmaceuticals
- Medical Devices
- Capa
- Sterilization
- Gamp
- Lean Manufacturing
- Lifesciences
- R&D
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