Specialist Quality Control 35191

Inteldot has over 15 years of experience in the life sciences industry, with allocations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.Job DescriptionUnder general direction, functions as the technical specialist for testing and 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.Administrative shift 8:00am – 5:00pm (subject to changing business needs and project priorities).RequirementsScientific Data AnalysisStrong Technical Writing (English and Spanish) mainly focusesStrong knowledge in Microsoft Excel as a Tool for Data AnalysisGood Communication skillsProject ManagementSample ManagementKnowledge in Computer System and Method Validation (Experience preferable)Strong knowledge and experience with quality process managementBasic Knowledge on equipment preventive maintenance and troubleshootingAgile on prioritization of critical tasksAbility to develop inspection or qualification protocols in a short timeframe period.Strong negotiation skillsFunctionsResponsible 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 necessaryEnsure lab compliance which includes Implementing procedures that enhance GMP, GLP and safety.Manage existing and/or develop and implement new programs, processes and methodologies.Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact.Approve lab investigations, Lead audit teamsMay serve as subject matter expert to develop technical training.May perform routine work in a specific area of responsibility as necessary.Represents the department/organization on various teams, independently responsible for following through on multi-site action items.May interact with regulatory agencies regarding area(s) of responsibility including written responses.May resolve issues with outside resources.EducationDoctorate or Masters + 2 years of directly related experience or Bachelors + 4 years of directly related experience or Associates + 8 years of directly related experience or High school/GED + 10 years of directly related experience.Preferable Scientific Background (Science or Engineering) with experience in Pharmaceutical Industry, Quality Control, Laboratory Testing, Project Management Method Validation, Method Transfer and Quality processes. Preferable experience as Microbiologist, Chemist, Biochemistry, Molecular Sciences, or Chemical Engineering.J-18808-Ljbffr