Software Validation Analyst

Company: KellyMitchell ( Learn More )

General Information
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Job Description

Primary Job Function

  1. Primarily responsible for basic level quality assignments, for example, reviewing/auditing, and authoring project documentation associated with the SDLC to support Corporate, Division, FDA, and other regulatory requirements.  
  2. This role assists with activity supporting the QA System and business driven objectives. Quality assurance will assist with project work related to:
    1. Infrastructure (Hardware or Layered Software Installations)
    2. Application quality
    3. Compliance initiatives
    4. Validations
    5. Internal / supplier audits
    6. CAPA system investigation, confirmation, or verification.

Job Responsibilities

  1. 1. Accountable for supporting project documentation for the software development lifecycle (SDLC for quality and non-quality applications.
  2. 2. Supports projects by:
    1. Reviewing test data and supporting validation documentation 
    2. Assisting with system design to help design in quality to systems
    3. determining validation strategies based on system design.
    4. Creating protocols to challenge system functionality
    5. Coordinate final package submission to QA library or other library projects as necessary
    6. Providing administration for validation review board meetings.
  3. Responsible for recognizing and elevating sensitive quality and regulatory issues for applications, layered software, & hardware.
  4. Recognize gaps in project documentation and recommend modification to the quality and non-quality systems.
  5. Assist in developing and maintaining written policies, processes, and procedures related to the quality system.


  1. Responsible for ensuring that Corporate and Divisional systems (applications, layered software, & hardware) are compliant to internal, FDA, and other regulatory requirements.


  1. Bachelors Degree, Science, IT, Business or Engineering 

Experience and Training

  1. Experience in a formal software development life cycle (minimum 5 years).  
  2. Experience in regulated software environment. (minimum 3 years)  
  3. Software Quality experience (Minimum 3 years), ).  
  4. Must be familiar with applicable US regulations (GMP parts 11, 58, 210, 211, and 820).  

Experiences that are considered a plus:

  1. Project Management 
  2. Auditing Experience 
  3. Quality Systems experience
Job Requirements