The posting
Job Description
About the Job:
The IHC Lead Technologist performs and leads day-to-day routine Immunohistochemistry (IHC) testing on patient samples in a high complex clinical diagnostic laboratory using a variety of automated platforms for microscopic examination and analysis by the Pathologist. The incumbent has a strong knowledge of accreditation and regulatory standards. In addition, the IHC Lead Technologist demonstrates a commitment to meeting TAT objectives, quality metrics, key performance indicators, and ensuring an environment of continuous improvement.
The IHC Lead Technologist may be asked to cover scheduling gaps and is included in the on-call rotation for additional weekend and/or holiday technical support.
This is a regulated position and additional information may be available from QA on the qualifications for this role pertaining to regulatory guidelines.
Regular onsite work at a designated FMI location is an essential function of this role.
Key Responsibilities:
- Lead day-to-day activities and workflow of the clinical IHC laboratory.
- Perform Automated Immunohistochemistry (IHC) using both the Dako Autostainer Link 48 and Ventana Benchmark Ultra Staining Systems.
- Operate a microtome to produce slides from paraffin blocks.
- Perform QC and/or verification steps for receiving and delivering specimens for IHC staining.
- Perform the assigned tests or components of the test in accordance with assay run schedule, accurately, and within TAT and always in compliance with written SOPs.
- Finalize test orders to deliver to requesting pathologist.
- Lead or coordinate tissue, reagent, and assay quality control and validations as needed.
- Perform routine H&E staining with possible other histological staining methods introduced over time.
- Maintain proper sample chain of custody including proper specimen handling, labeling, and preparation of batch records.
- Maintain adequate stock and efficient use of supplies necessary for performing all procedures, and preparation of reagents as required.
- Assist in maintaining an organized lab space.
- Follow written lab Standard Operating procedures for the correct handling and processing of specimens.
- Maintain a deep understanding of laboratory processes to ensure effective troubleshooting of assays and instrumentation.
- Serve as a technical resource for problem solving and process improvement to ensure accurate test performance and meets all quality goals.
- Demonstrate capability of identifying problems that may adversely affect test performance or reporting of tests results and takes appropriate action.
- Maintain attention to detail for quality completion of each task.
- Maintain and troubleshoot equipment/instrumentations.
- Communicate with the Asset Management team and IHC Supervisors when equipment needs repair.
- Assist in the development of competency, training, and orientation of the IHC staff.
- Support department supervisor on any employee related concerns.
- Effectively communicate deficiencies to appropriate personnel, including deficiencies related to specimens, paperwork, database information, and equipment.
- Investigate Root Cause Analysis (RCA), write Incident/Event Report (INC), Non-Conformance Report (NCR), and Corrective Action & Preventative Action (CAPA).
- Troubleshoot issues while working with staff to document the quality issues.
- Participate on cross-functional teams to coordinate troubleshooting, process improvements, SOP revisions, and/or implement new workflows or products.
- Monitor and communicate inventory of supply and reagent needs as they diminish.
- Assist with equipment validation (find cases, work through optimization, etc.) and work with outside vendors, when required.
- Operate and maintain all IHC lab equipment in proper state of readiness and cleanliness. Record and monitor monthly logs for all required areas.
- Collect and publish routine processing and operational metrics and execute countermeasures to ensure daily processing goals are met.
- Ensure that quality tissue specimen slides and stain results are obtained and delivered to the Pathologist within established quality standards.
- Adhere to laboratory’s quality control policies (GCP, CAP/CLIA, ISO) and document all quality control activities with the ability to recognize outliers and correct them.
- Oversee CAP surveys and CAP checklist (IHC)
- Support the lab supervisors with maintaining and publishing the lab schedule and/or processing metrics
- Participate in biohazard, chemical, and general safety and other continuing education programs.
- Receive and transmit telephone calls and/or emails regarding patient sample processing.
- Resolve high volume email inquiry request.
- Perform other duties as assigned.
- Comply with FMI's attendance policies
Qualifications:
Basic Qualifications:
- Bachelor’s degree in biological or life sciences
- 5+ years of Histology laboratory work experience in a CAP/CLIA regulated laboratory
- 5+ years’ experience working with Dako, Leica, or Ventana Autostainer
- Qualifies as 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 Clinical Pathology (ASCP) certification is required within 6 months of hire
Preferred Qualifications:
- 6+ years of laboratory work experience in a CAP/CLIA regulated lab
- 6+ years of experience in Histology experience
- 6+ years of experience in Immunohistochemistry testing (manual and automated)
- 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 for successful execution of project and
- program goals
- Demonstrated experience handling multiple tasks at once
- Demonstrated Ability to: Work independently as well as collaborate with peers in a fast-paced and cross-functional Utilize a laboratory information management system (LIMs, MS Office esp. Excel) Work well under pressure while maintaining a professional demeanor Prioritize and thoroughly follow up on assigned tasks Adapt to changing procedures, policies and work environment Perform work in a lab environment in the presence of chemicals and reagents Learn new tasks in appropriate timeframes Prioritize and thoroughly follow up on assigned tasks Understand and communicate scientific or technical information
- Strong interpersonal skills that include excellent skills in written and oral communication,
- collaboration, and problem solving
- Demonstrated attention to detail and strong organizational skills
- Understanding of HIPAA and the importance of patient data privacy
- Commitment to reflect FMI’s values: Integrity, Courage, and Passion
The expected salary range for this position based on the primary location of Morrisville, NC is $62,800 - $78,500 per year. The salary range is commensurate with Foundation Medicines compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.
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About Us
Foundation Medicine, Inc. (FMI) is a global, patient-focused precision medicine company delivering high-quality, transformative diagnostic solutions in cancer and other diseases.
Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI's EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form. (EOE/AAP Employer)
