Validation Specialist

Location: Amherst, NY

Description: Frontier Science Foundation (FSF) is a not for profit data management and statistical center with several offices located in the United States. Our work is funded both from government agencies such as the NIH as well as large pharmaceutical sponsors for various clinical trial projects. FSF is seeking an enthusiastic and motivated candidate who will oversee all commercial software validation efforts and create validation packages in compliance with 21 CFR Part 11. Candidates will be working in a dynamic, collaborative environment and should be comfortable multi-tasking.

Duties:

  • Oversee validation of all commercial software applications, which includes:
    • Working with office leaders to assemble and subsequently lead a validation team for each commercial system
    • Advising office leaders on requirements for systems validation when new software systems are introduced, including compliance requirements for 21 CFR Part 11
    • Participating in vendor training to learn required functionality of the system
    • Compiling commercial off the shelf validation package for each software version in accordance with FDA expectations in 21 CFR Part 11
    • Updating validation deliverables for system for upgrades, fixes, new versions, or any other potential change in functionality
  • Perform vendor audits in accordance with a predetermined vendor audit schedule

Education: A Bachelor's degree

Skills:

  • Experience with computer systems validation, specifically within the context of a GCP or GxP environment
  • Proficient in writing and/or executing user acceptance test cases
  • Familiarity with Federal regulations affecting clinical trial data management work such as relevant FDA regulations and 21 CFR Part 11
  • Strong writing skills and the ability to produce documentation using proper English and grammar and in a manner to be understood by general staff and management
  • Excellent communication and interpersonal skills, along with the ability to facilitate discussion and gather information for the development of documentation or other software training materials
  • Resourceful, positive and professional demeanor
  • The ability to build effective relationships and work with people from diverse backgrounds, work independently, multi-task, adapt to changing priorities, perform job duties with minimal guidance, and meet deadlines

Email resume/cover letter to jobs@fstrf.org and include ValSpec202008 in the subject line.

All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, disability, age, or veteran status.