Histotech, Clinical Trials
About The Position
The Histotechnologist, Clinical Trials supports testing activities within the Biopharma CDx Services CAP-CLIA laboratory for clinical trials. Testing personnel are responsible for specimen processing, test performance, and reporting test results. The position performs only high-complexity tests authorized by the laboratory director and appropriate to the employee’s education, training, experience, and technical abilities. The role applies advanced histology knowledge and technical expertise to laboratory activities, technical troubleshooting, quality and regulatory compliance, and continuous improvement. The Histotechnologist performs complex histology work independently within established procedures and qualifications, and may perform IHC testing under the direct supervision of qualified personnel. The position also supports quality-control and maintenance activities, inspection readiness, and laboratory training and guidance.
Requirements
- Bachelor’s degree in chemical, physical, or biological sciences, or a related discipline meeting applicable CLIA requirements for testing personnel.
- Typically 4+ years of relevant laboratory experience, including histology, histotechnology, or a closely related laboratory environment.
- Histotechnologist HTL(ASCP) or Histotechnician HT(ASCP) certification.
- Ability to perform laboratory activities with minimal direction, identify and troubleshoot technical issues, and work effectively within established quality and regulatory procedures.
Nice To Haves
- Experience working in a CLIA-regulated laboratory is desired.
Responsibilities
- Follow laboratory procedures for specimen handling and processing, test analyses, and reporting and maintaining patient test results.
- Independently perform complex histology laboratory activities within established procedures, regulatory requirements, and individual testing qualifications.
- Perform IHC testing when applicable under the direct supervision of a qualified technologist, technical supervisor, or other qualified pathologist.
- Prepare tissue specimens by sectioning and staining samples for microscopic analysis, following established guidelines.
- Identify and troubleshoot technical issues affecting specimen quality, test performance, or reporting; take corrective action or promptly notify appropriate laboratory leadership as required.
- Follow established policies and procedures when test systems are outside acceptable performance levels, and document corrective actions when systems deviate from specifications.
- Perform and document quality-control activities, instrument and procedural calibrations, preventive maintenance, and equipment maintenance or certification.
- Maintain records showing proficiency-testing samples are tested in the same manner as patient specimens.
- Keep the laboratory clean, functional, and inspection-ready.
- Contribute to laboratory quality initiatives and improvements to procedures, workflows, and operational processes.
- Support CAP-CLIA inspection readiness and other applicable regulatory and quality activities.
- Serve as a technical resource and potentially train or guide less-experienced laboratory personnel.
- Maintain appropriate filing and storage of completed tissue blocks and slides.
- Plan, coordinate, and prioritize assigned laboratory activities with minimal direction while following established procedures and regulatory requirements.
Benefits
- Eligible for bonus, stock, and benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
