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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.

 

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.

Regular onsite work at a designated FMI location is an essential function of this role.

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

 

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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Internal applicants, please use your FMI email address.

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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)

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