Person, Text, Face

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.

Qualifications

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

Apply Now

Internal applicants, please use your FMI email address.

Please let me know about more jobs like this

Not You?

Thank you

Recommended Jobs

Senior Analyst, Data Analytics

Strategic Insights, Analytics and Enablement 100533 Cambridge Massachusetts United States Second Street, Cambridge, Massachusetts, United States Strategic Insights, Analytics and Enablement
About the Job The Sr Analyst, Data Analytics in Strategic Insights & Analytics (SI&A) works with stakeholders across FMI to generate new and actionable insights to support strategy development, tactical planning, and execution, as well as...

Client Services Associate (12pm-8:30pm Shift)

Client Services 100527 Morrisville North Carolina United States Kit Creek Road, Morrisville, North Carolina, United States Client Services
About the Job The Client Services Representative is a vital position at FMI tasked with the responsibility of responding to and resolving a wide range of client inquiries and requests as well as acting as a liaison between departments within FMI,...

Finance & Accounting Intern (Undergraduate)

Corporate Management 100547 Cambridge Massachusetts United States Second Street, Cambridge, Massachusetts, United States Corporate Management
About the Job The Intern, Finance and Accounting role works with many areas of the broader Corporate Management Team, dependent upon the relevant needs of the team throughout the summer. This includes general ledger accounting, cost accounting, a...

Accessioning Technician II

Lab Operations 100506 Morrisville North Carolina United States Kit Creek Road, Morrisville, North Carolina, United States RTP Lab Operations
About the Job The Accessioning Technician II performs critical sample receipt and data entry functions in FMI’s CLIA-certified clinical laboratory.  Specifically, the Accessioning Technician II receives incoming samples and ensures that necessary...

Send to a friend

Not You?

Thank you for sending this job to your friend.

Person, Clothing, Shoe, Crowd, Sitting, People, Wood, Pants, Face, Coat