Software Validation Analyst

We are a Santa Monica-based Internet company that deals in the cutting-edge of Web-centric electronic medical records. Our clients are all over the U.S. and we are starting to expand into international territories. Our mission-critical Web-based software directly assists dedicated medical professionals in thousands of lives being saved and improved every year through the miracle of organ, tissue and eye transplantation.

We are currently looking for a highly-motivated and energetic, Software Validation Analyst to join our team.

At Transplant Connect you will have the opportunity to support our Quality Assurance Team in developing, delivering and enforcing fully validated and documented systems and software that meet regulatory body requirements. The Software Validation Analyst will be accountable for writing and executing validation test scripts that will be used to ensure that iTransplant systems meet the standards set forth by the project requirement specifications, Transplant Connect standards and the applicable FDA regulatory requirements.

The qualified candidate will have a minimum of 1-2 years experience in the software development industry, working knowledge of the software development process, high attention to detail and excellent organizational and communication skills.

Position Summary: Software Validation - Job Description:
  • Prior experience creating Test Scripts from User Requirements Specification
  • Understands the Validation requirements of software regulated by FDA
  • Familiarity with Traceability Matrix
  • High attention to detail and excellent organizational and communication skills
  • Will work closely with the QA Manager to create and execute Test Plans and Test Scripts accurately.
  • Error detection and logging via our in-house issue-tracking system
  • Working with the QA staff to document test script results
Skills Required:
  • Minimum 1-2 years experience as a Software Validation Analyst/Quality Assurance analyst (some of the testing experience must be in a non-automated testing environment).
  • Experience testing .NET applications for web based application.
  • Excellent verbal and written communication skills required.
  • Experience working with a team in a collaborative environment.
  • Energetic, positive attitude, ability to motivate others.
  • Analytical, focused, with meticulous attention to detail required.
  • Must demonstrate the ability to create a test plan and test scripts for a software application.
  • Familiarity with HIPAA, FDA Good Tissue Practices (GTP), and/or Medical Records a plus.
  • Proficiency in Microsoft Word and Excel required.
Education: BS/BA is recommended (Computer Science or related discipline)
Applicants must be authorized to work in the U.S. without employer sponsorship