Doctorate degree in Sciences/Engineering or Master’s degree in Sciences/Engineering & 3 years of directly related experience or Bachelor’s degree in Sciences/Engineering & 5 years of
directly related experience
Experience in the creation of systems visualizations using tools such as Spotfire / Tableau
Direct experience in the support and maintenance of laboratory electronic systems (LIMS / CIMS / LMES)
Template Creation & Maintenance
Skilled on data analysis by developing reports using SQL like tools(SQL / Brio / Cognos )
Customer service oriented by able to support our clients on technical needs related to QC electronic systems
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 scop e 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. 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 teams May 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. Performs special projects as requested by supervisor, May supervise employees as necessary to meet technical requirements.
Education/Licenses : Doctorate degree or Master’s degree & 3 years of directly related experience or Bachelor’s degree & 5 years of directly related experience or Associate’s degree & 10 years of directly related experience or High school diploma / GED & 12 years of directly related experience.
Competencies/Skills: Understand, support and demonstrate the CLIENT SITE values. Excellent communication skills, facilitation and presentation skills. Excellent technical writing skills. Strong computer operation skills including work processing, presentation, database and spreadsheet application skills, Excellent project management and organizational skills including the ability to independently understand, follow, implement complex instructions and follow assignments through to completion. Advanced skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities. Excellent knowledge of and experience with processes involved in quality analytical labs, validation, manufacturing, quality assurance, process development and distribution.