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.
• 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.