QCAT Senior Scientist:in (m/w/x) R-290144
Core
Conduct performance qualification for analytical methods and support device implementations in a GMP-regulated environment.
Role type
Senior Scientist (Quality Control)
Builds
Validated analytical methods and project documentation for medical device/therapeutic production
Domain
Life Sciences / Quality Control / GMP
Required skills
Analytical chemistry, Biochemistry, Microbiology, Method validation, Project management, SOP creation, Technical mentoring
Preferred skills
Experience with innovative technologies, Regulatory submission support
Technologies
GMP systems, Analytical instrumentation
Responsibilities
Plan and execute projects for new method implementation and improvement, Create project plans with resource estimation, Support regulatory submissions as subject matter expert, Create and review study documents (SOPs, reports), Provide technical guidance to colleagues
