Person, Text, Face

 

Every patient sample is a story.

That's why our Lab Ops team is focused on providing physicians with comprehensive genomic information about each person's cancer. Information that's as unique as the patients are. The insights discovered in our labs may help change their story.

 

IHC Technical Specialist

  • Kit Creek Road, Morrisville, North Carolina, United States
  • Full Time

About the Job

The IHC Technical Specialist troubleshoots, supports and performs 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 serves as a technical resource for problem solving and process improvement to ensure accurate test performance and meet all quality goals. As needed, the incumbent is expected to flex and provide coverage due to scheduling gaps and will be included in the on-call rotation for additional weekend and/or holiday technical support.

Key Responsibilities

  • Supports and troubleshoots 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.
  • Responsible for equipment and assay validations for clinical and research purposes.
  • Leads or coordinates tissue, reagent and assay quality control, validations and projects as needed.
  • Maintain a deep understanding of laboratory processes to ensure effective troubleshooting of assays and instrumentation.
  • Identify problems that may adversely affect test performance or reporting of tests results and takes appropriate action
  • Communicates with the Asset Management team and IHC Supervisors when equipment needs repair.
  • Effectively communicate deficiencies to appropriate personnel, including deficiencies related to specimens, paperwork, database information, and equipment
  • Guide and train newer, less-experienced lab personnel to become proficient with routine procedures and protocols.
  • Investigate Root Cause Analysis (RCA), write Incident/Event Report (INC), Non-Conformance Report (NCR), and Corrective Action & Preventative Action (CAPA)
  • Collaborate on SOPs revisions and drafts as needed to adjust for process improvement initiatives and regulatory changes
  • Troubleshoots issues while working with staff to document the quality issues.
  • Participates 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.
  • Direct contact for outside vendors when machines are having issues.
  • Transcribes and records data and develops the ability to contribute to data interpretation and analysis.
  • Assist in drafting presentations or reports stemming from scientific contributions in the laboratory.
  • Assist with implementation of new instruments, equipment, and assays
  • Collect and publish routine processing and operational metrics and execute countermeasures to ensure daily processing goals are met
  • 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.
  • Resolve high volume email inquiry request.
  • Communicate effectively in a courteous, professional manner with all levels of management, co-workers, and clients to provide quality customer service
  • Perform other duties as assigned.

Qualifications

Basic Qualifications

  • Bachelor’s degree, particularly a Bachelor of Science 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
  • 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

  • Bachelor’s degree, particularly a Bachelor of Science degree in biological or life sciences
  • 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)
  • Demonstrated experience working within tight timelines for successful execution of project and
  • program goals
  • Ability to work independently as well as collaborate with peers in a fast-paced and cross-functional results-oriented team environment
  • Ability to work well under pressure while maintaining a professional demeanor
  • 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 importance of privacy of patient data
  • Experience with antibody validation is preferred.
  • Familiarity with Laboratory Information Management Systems (LIMS)
  • Understanding of HIPAA and importance of privacy of patient data
  • Commitment to FMI values: patients, innovation, collaboration, and passion

#LI-Onsite

 

Please be aware that Foundation Medicine mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.

 

About Foundation Medicine

Foundation Medicine, Inc. (FMI) began with an idea—to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.

Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us. At Foundation Medicine there's no such thing as the 'perfect' applicant, and our company is a place where every employee can make an impact and continue to grow whatever background they may have or path they may have taken. So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.

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