Clinical Software Validation Specialist

At Genospace, our mission is to be the leading information platform for applied precision medicine.
 
Working from our headquarters in Boston, MA, our interdisciplinary team is merging the tools and techniques of genomics, analytics, and cloud computing. We serve research, clinical development, pathology, and clinical care customers who work with high-dimensional genomic and other biomedical data. Many of the most advanced precision medicine organizations are powered by Genospace.

Genospace is looking for talented team players who enjoy a challenge and want to help us deliver our platform. As the leading provider of information technology services in molecular medicine, our software is used today by clinicians and researchers across the country and around the globe to improve patient care.

What You’ll Do:

As a Clinical Software Validation Specialist at Genospace you will play a crucial role in ensuring that product development teams deliver functionally correct and complaint software in a regulated environment. You will support product innovation by developing novel and creative software validation processes and encourage automation early and often.

What We’re Looking For:

  • Extensive experience implementing software quality processes in a scrum/agile development environment
  • Demonstrated success with software validation automation
  • Prior experience with health and life sciences data processing systems
  • First hand experience validating web applications for FDA Quality System Regulations
  • Experience with defect tracking systems and defining and tracking software
  • Familiarity with quality metrics and analysis

Education & Background:

  • Bachelor’s degree or equivalent experience
  • Minimum of 5 years of practical work experience defining, documenting, and executing software/system verification and validation
  • Minimum of 5 years of experience working in a regulated industry, with particular experience with 21 CFR Part 11 and GAMP 5

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