Lab Scientist

Our client develops, manufactures and supplies a wide array of innovative medical diagnostic products, services, tests, platforms and technologies. Summary: Responsible for performing high complexity laboratory testing on clinical specimens, interpreting and reporting results and complying with study protocols, Standard Operating Procedures, Test Instructions, and related CAP/CLIA Regulations and guidelines. Participates in scientific studies and activities supporting registrational and non-registrational clinical trials. Receives general instructions; plans and executes own work. Responsibilities: Works under general supervision, to support aspects of clinical testing and sample processing, adhering to CAP/CLIA regulations and ISO 15189 guidelines. Performs high complexity testing within the CDx CAP/CLIA Laboratory. Monitors performance of IHC, ISH, molecular assays, and immunoassays; assists with lab failure investigations and root cause analysis. Performs accessioning of biological samples (blood, plasma, tissue) and quality control of demographic data input. Communicates with clients on held and rejected samples. Performs work according to established internal safety guidelines and procedures, and as specified by appropriate regulatory agencies (SHE, OSHA) Critically evaluated quality control and test results against acceptance criteria to support clinical testing. Uses technical writing skills and Good Documentation Practices to complete lab documentation, SOPs, and Quality documents. Participate in routine lab maintenance and lab safety inspections. May perform basic troubleshooting for issues related to instrumentation. Analyzes alternative approaches to solve problems or develop new perspectives on existing solutions; initiate and implement process improvements. Qualifications: To perform this job successfully, an individual must be able to perform each responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the responsibilities. Formal Training/Education: Must possess a BS or BA degree in a related discipline 1 year experience working in a clinical laboratory Immunohistochemistry (IHC), chromogenic in-situ hybridization (ISH), histology lab experience (CAP/CLIA), immunoassays and molecular biology experience