About the Job
The Genomics Analysis & Reporting (GAR) Specialist I provides operational excellence within the team by contributing to quality and process improvement efforts. This role is integrated within a team of scientists to carry out organizational and operational tasks in support of Foundation Medicine’s clinical and pharma reporting process. This role will also support departmental operational improvement projects.

Key Responsibilities

• Provide operational excellence within the Genomics Analysis and Reporting (GAR) Team. 
• Schedule, coordinate, and perform daily and weekly operational tasks. 
• Set up and maintain internal systems (SmartSheet, Confluence, JIRA, Excel, Veeva) for new and existing projects and deliverables in GAR with input from key cross-functional stakeholders. 
• Create and maintain action / issue logs and proactively manage completion of assigned tasks. 
• Support Genomics Analysis and Reporting Team compliance with QA requirements by maintaining up-to-date SOPs and WIs and contributing to NCR, PDA, CAPA, and any other regulatory compliance documentation as required. 
• Contribute to cross-functional team efforts and liaise with internal stakeholders quickly to resolve technical issues and questions that arise. 
• Participate in the triage of on-call requests directed towards the Genomics Analysis and Reporting Team. 
• Support collection of and analysis of operational metrics. 
• Ability to manage multiple projects, timelines, and responsibilities in parallel. 
• Follow company policies and applicable procedures. 
• Deliver on tight deadlines. 
• Execute work with adherence to GCP requirements and applicable regulations including, but not limited to, CLIA, CAP, MA state, NY state. 
• Other duties as assigned. 

Qualifications

Basic Qualifications

• Bachelor’s Degree 
• Prior experience working within the Clinical Oncology industry 

Preferred Qualifications

• Background or degree in a scientific discipline 
• 1+ year(s) clinical operational experience 
• 1+ year(s) of editing and/or proofreading experience 
• Familiarity with clinical laboratory and/or medical device technologies and quality systems 
• Demonstrated ability to: 
  • Meet project deadlines 
  • Prioritize and thoroughly follow up on assigned tasks 
  • Perform assignments with minimal supervision 
  • Work well under pressure while maintaining a professional demeanor 
  • Handle multiple tasks at once and work in a fast-paced environment 
  • Adapt to changing procedures, policies and work environment 
  • Clearly communicate and present information to a wider audience 
• Demonstrated history of creativity and innovation 
• Strong problem-solving skills that enable identification of root causes and targeted solutions 
• Strong attention to detail 
• Excellent interpersonal skills, including written communication, oral communication, collaboration, and problem solving with other departments and colleagues both virtually and in person 
• Understanding of HIPAA and importance of patient data privacy 
• Demonstrated integrity and a commitment to values held at FMI: patients, innovation, collaboration, and passion.

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