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Histology System Specialist

  • Second Street, Cambridge, Massachusetts, United States
  • Full Time

About the Job

The Specialist, Histology Systems is responsible for providing support to the Histology and Immunohistochemistry teams within Laboratory Operations in the oversight of all system procedures, assay development, equipment implementation, validation, and optimization. 

This is a regulated position and additional information may be available from QA on the qualifications for this role pertaining to regulatory guidelines.

Key Responsibilities

• Manage the IQ/OQ/PQ processes within the Histology laboratory, including drafting, reviewing and executing these processes.

• Enforce laboratory compliance for CAP/CLIA/ISO/FDA audits.

• Identify and implement process improvements that streamline operations and optimize workflows.

• Validate and implement CLIA/FDA-certified tests, including writing SOPs and validation plans/reports.

• Work with the Laboratory Information Management Systems team to successfully develop, implement and maintain information management in the laboratory.

• Lead the implementation of new IHC testing protocols and equipment.

• Ensure preventative maintenance is completed on all equipment.

• Perform complex clinical histology laboratory activities, as directed.

• Oversee the training and development of new employees.

• Continually assess the competency of current histology employees.

• Act as a key decision maker in hiring process for new team members.

• Collaborate effectively with team leads.

• Other duties as assigned.


Basic Qualifications

• Bachelor’s degree in a scientific discipline

• 4+ years of experience working in a regulated clinical laboratory environment (CLIA/CAP/NYSDOH/QSR)

• 3+ years of experience in project management

Preferred Qualifications

• HT or HTL ASCP Certification

• General Supervisor designation according to CAP regulations

• Lean Six Sigma experience/certified

• 2+ years of experience creating laboratory SOPs

• 3+ years of experience with instrument validating and optimization

• Proven track record of working as a leader within a histology laboratory teams

• Experience ensuring clinical laboratory compliance to regulatory standards.

• Knowledge of laboratory safety protocols

• Experience with Laboratory Information Management System (LIMS)

• Experience creating and leading process improvements which impact the business unit

• Experience working with cross-functional teams and task forces

• Strong written and verbal communication skills, including the ability to clearly communicate business processes and solutions

• Strong organizational and time management skills, including the ability to multitask in a fast-paced environment

• Ability to adapt to changing procedures, policies and work environment

• Ability to work independently as well as part of a team

• Ability to work full-time in a laboratory environment

• Proficiency utilizing Microsoft Office Suite, specifically Excel and Power Point

• Understanding of HIPAA and importance of privacy of patient data

• Commitment to FMI values: patients, innovation, collaboration, and passion

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