Lab Scientist
5 days ago
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
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