• Maintain requirement and design specifications as well as other documentation required for software development and change control processes.
• Work independently as well as collaborate in a larger team setting.
• Author and revise documentation of environment and operation procedures as needed.
• Provide support to internal FMI customers of CBE applications.
• Maintain availability to work outside of regularly scheduled shift.
• Other duties as assigned.
• Bachelor's Degree
• 4+ years of experience in a related area, with a focus on testing or requirements management
• Familiarity with requirements definition and management as related to a software development life cycle
• Experience with Good Practice (GxP) quality guidelines and specific regulations, including but not limited to:
· Clinical Laboratory Improvement Amendments (CLIA);
· Good Clinical Practice (GCP);
· College of American Pathologists regulations;
· 21 CFR Part 11 compliance;
· Food and Drug Administration and FDA Good Manufacturing Process;
· Massachusetts state regulations; and,
· New York state regulations
• Familiarity with genomics and/or computational biology
• Strong interpersonal skills that include skills in written and oral communication, collaboration, and problem solving with departments and colleagues
• Excellent attention to detail
• Understanding of HIPAA and importance of privacy of patient data
• Commitment to FMI’s core values: patients, passion, collaboration, and innovation
Internal applicants, please use your FMI email address.
The Research and Development team at Foundation Medicine is constantly pushing the envelope to transform cancer care.
Watch the video to see how each member has the chance to make a real impact.