JOB 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.
• Other duties as assigned by management.
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:
Bachelor's Degree Must possess a BS or BA degree in a related discipline
Experience:
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.
Knowledge, Skills and Abilities:
• Demonstrated proficiency in computer skills, such as word processing, statistical analysis, and laboratory information systems.
• Excellent verbal and written communication skills.
• Strong understanding of good laboratory practices and regulatory compliance.
• Requires excellent attention to detail; ability to multi-task and be flexible with tasks and schedules.
Travel Requirements:
As needed Based on business needs
Pay Rate: $27-30/Hr *Salary will be commensurate with candidate experience
