Specialist Quality Complaints - 28963

Descripción del Empleo:
Mus be available for 2nd & 3rd shift & Must be Fully Bilingual (English & Spanish).

Under general direction, functions as the technical specialist for testing & development in areas of molecular biology and microbiology. Focus is on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources. Functions: Responsible for providing technical guidance, provide reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise. Resolve technical issues and troubleshoot for assays as necessary, ensure lab compliance – which includes implementing procedures that enhance GMP, GLP and safety.
Requisitos:
Doctorate degree in Sciences or Master’s degree in Sciences & 3 years of directly related experience or Bachelor’s degree in Sciences & 5 years of directly related experience
• BS in Chemistry or Biochemistry preferred
• Knowledge in TrackWise, CDOCS, Maximo
• Knowledge in PowerPoint, Excel, Word, One Note
Expertise in Technical Writing, must have written reports for investigations, method transfers/validations,
• Root Cause Analysis experience and CAPA identification and implementation
• Fully bilingual English/Spanish
• Meeting and conference calls facilitator, with multilevel audience (Upper level Management to analysts)
• Presentation skills
• Oriented to solve problems and troubleshoot, technical proficiency
• Simple statistical assessments