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)