CONTRACT
MUST HAVES:
- Bachelor's Degree Must possess a BS or BA degree in a related discipline
- 1 year experience working in a clinical laboratory, histology laboratory (CAP/CLIA), or similar laboratory setting
- Experience and/or knowledge of Immunohistochemistry (IHC), chromogenic in-situ hybridization (ISH), immunoassays and molecular biology techniques
Description:
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.
Education Level:
• Bachelor's Degree Must possess a BS or BA degree in a related discipline (REQUIRED)
Years of Experience:
• 1 year experience working in a clinical laboratory (PREFERRED)
• Immunohistochemistry (IHC), chromogenic in-situ hybridization (ISH), histology lab experience (CAP/CLIA), immunoassays and molecular biology experience. (PREFERRED)
Knowledge, Skill or Ability:
• Demonstrated proficiency in computer skills, such as word processing, statistical analysis, and laboratory information systems. (REQUIRED)
• Excellent verbal and written communication skills. (REQUIRED)
• Strong understanding of good laboratory practices and regulatory compliance. (REQUIRED
• Requires excellent attention to detail; ability to multi-task and be flexible with tasks and schedules. (REQUIRED)
