IHC Lead Technologist

Foundation Medicine•Morrisville, NC

12d•$62,800 - $78,500•Onsite

About The Position

The IHC Lead Technologist leads day-to-day routine immunohistochemistry testing on patient samples in a high-complexity clinical diagnostic laboratory. The role uses a variety of automated platforms to prepare samples for microscopic examination and analysis by a Pathologist. The technologist is expected to understand accreditation and regulatory standards and support turnaround-time objectives, quality metrics, key performance indicators, and continuous improvement. The role may cover scheduling gaps and participates in an on-call rotation for additional weekend and/or holiday technical support. It is a regulated position, and regular onsite work at a designated Foundation Medicine location is an essential function. The position is based primarily in Morrisville, North Carolina.

Requirements

Bachelor’s degree in biological or life sciences.
At least 5 years of histology laboratory work experience in a CAP/CLIA-regulated laboratory.
At least 5 years of experience working with a Dako, Leica, or Ventana Autostainer.
Qualification as a General Supervisor according to CAP regulations.
Certification as a Histology Technician (HT) or Histology Technologist (HTL), and/or Qualification in Immunohistochemistry (QIHC) from the American Society for Clinical Pathology (ASCP), required within 6 months of hire.
Ability to work independently and collaboratively with peers in a fast-paced, cross-functional environment.
Ability to use a laboratory information management system (LIMS) and Microsoft Office, especially Excel.
Ability to work under pressure while maintaining a professional demeanor.
Ability to prioritize and thoroughly follow up on assigned tasks.
Ability to adapt to changing procedures, policies, and work environments.
Ability to work in a laboratory environment in the presence of chemicals and reagents.
Ability to learn new tasks within appropriate timeframes and understand and communicate scientific or technical information.
Strong written and oral communication, collaboration, interpersonal, and problem-solving skills.
Demonstrated attention to detail and strong organizational skills.
Understanding of HIPAA and patient-data privacy.
Commitment to FMI’s values of Integrity, Courage, and Passion.
Regular onsite work at a designated FMI location.

Nice To Haves

At least 6 years of laboratory work experience in a CAP/CLIA-regulated laboratory.
At least 6 years of histology experience.
At least 6 years of experience in manual and automated immunohistochemistry testing.
Familiarity with Laboratory Information Management Systems (LIMS).
Relevant experience in a regulated laboratory environment, such as CAP/CLIA.
Basic knowledge of laboratory safety protocols.
Demonstrated experience working within tight timelines to execute project and program goals successfully.
Demonstrated experience handling multiple tasks at once.

Responsibilities

Lead day-to-day activities and workflow in the clinical IHC laboratory.
Perform automated immunohistochemistry using Dako Autostainer Link 48 and Ventana Benchmark Ultra staining systems.
Operate a microtome to produce slides from paraffin blocks.
Perform quality control and verification steps for receiving and delivering specimens for IHC staining.
Perform assigned tests or test components accurately, according to the assay run schedule, within turnaround-time targets, and in compliance with written SOPs.
Finalize test orders for delivery to the requesting Pathologist.
Lead or coordinate tissue, reagent, and assay quality control and validations as needed.
Perform routine H&E staining and potentially other histological staining methods introduced over time.
Maintain sample chain of custody through appropriate specimen handling, labeling, and batch-record preparation.
Maintain adequate supplies, use them efficiently, and prepare reagents as required.
Help maintain an organized laboratory space.
Follow written laboratory SOPs for specimen handling and processing.
Troubleshoot assays and instrumentation using a thorough understanding of laboratory processes.
Serve as a technical resource for problem-solving and process improvement to support accurate test performance and quality goals.
Identify issues that could adversely affect test performance or reporting and take appropriate action.
Maintain attention to detail and quality in completing tasks.
Maintain and troubleshoot equipment and instrumentation, and communicate repair needs to Asset Management and IHC Supervisors.
Assist with competency development, training, and orientation of IHC staff, and support the department supervisor with employee-related concerns.
Communicate deficiencies involving specimens, paperwork, database information, or equipment to the appropriate personnel.
Investigate root causes and prepare Incident/Event Reports, Non-Conformance Reports, and Corrective Action and Preventative Action documentation.
Troubleshoot issues with staff and document quality issues.
Participate in cross-functional teams addressing troubleshooting, process improvements, SOP revisions, and implementation of new workflows or products.
Monitor inventory and communicate supply and reagent needs as stock diminishes.
Assist with equipment validation, including identifying cases and working through optimization, and work with outside vendors as needed.
Operate and maintain IHC laboratory equipment in a clean and ready state, and record and monitor required monthly logs.
Collect and publish routine processing and operational metrics and execute countermeasures to meet daily processing goals.
Ensure quality tissue specimen slides and stain results are delivered to the Pathologist within established standards.
Follow laboratory quality-control policies, including GCP, CAP/CLIA, and ISO requirements; document quality-control activities, recognize outliers, and correct them.
Oversee CAP surveys and the IHC CAP checklist.
Support laboratory supervisors in maintaining and publishing the laboratory schedule and processing metrics.
Participate in biohazard, chemical, general safety, and other continuing-education programs.
Receive and transmit telephone calls and emails regarding patient sample processing, and resolve high-volume email inquiries.
Perform other assigned duties and comply with FMI attendance policies.