IT Validation and Systems Analyst

Published March 21st, 2024

Key Responsibilities:
 

  • Creation and execution of various computer system validation deliverables, and activities for GxP system projects.
  • Function as a business analyst for GxP systems working with business owners and SMEs to elicit requirements and document processes in support of delivering new business capabilities.
  • Provide system operational support including but not limited to management of system access and minor system changes.
  • Strong technical writing skills in creating and writing GxP relevant documents including but not limited to Standard Operating Procedures (SOP), Work Instructions (WI), user guides.
  • Part of team supporting GxP system implementation initiatives, and existing system enhancements. Tasks may include requirements gathering, application design, testing and necessary validation and documentation support.
  • Coordinate with external vendors to analyze and resolve issues.
  • Provide helpdesk support resolving problems relating to GxP business applications collaborating with internal IT team and external vendors to provide excellent support experience for end users.
  • Performs related duties as assigned or requested.
     

Required Skills & Experience:
 

  • Bachelor’s degree required.
  • Must have minimum of 5+ years of relevant experience in biotech or life sciences industry working in a GxP environment.
  • Strong working knowledge of 21 CFR Part 11 and GxP computer system validation principle and process.
  • Must be able to work with different functional team members, external vendors and have ability to work independently.
  • Strong written and verbal communication skills.
  • Must be able to work on multiple initiatives simultaneously and prioritize assignments to deliver quality work in a timely manner.
  • Enthusiastic, motivated fast learner and willing to work in an energetic, fast-paced team environment.
  • Familiarity with Annex 11, HIPAA, and data integrity and security
     

Preferred Skills and Experience:
 

  • Experience with GxP systems such as Veeva QDocs, QMS, RIM, ComplianceWire, DocuSign Part 11 is preferred.
  • Project management skillset and experience is preferred.
  • Advanced degree is a plus.
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