Validation Specialist

4 weeks ago


Middleton, Wisconsin, United States Intellectt Inc Full time
Job Title: Validation Analyst

At Intellectt Inc, we are seeking a highly skilled Validation Analyst to join our team. As a key member of our team, you will be responsible for ensuring the quality and integrity of our software systems.

Key Responsibilities:
  • Participate in project team meetings and complete assigned action items, providing direction for future releases and reviewing change requests.
  • Provide validation support for new releases and modifications to applications throughout the software development life cycle, preparing validation plans, test cases, and validation summary reports.
  • Review and approve all change controls associated with validated systems and review PQ and change control documentation with leadership.
  • Ensure test scripts challenge functional requirements and adequately demonstrate that the application meets business expectations.
  • Execute test scripts accurately to produce evidence that the computer system consistently performs its intended functions accurately and reliably.
  • Manage assignments to meet deadlines and produce high-quality deliverables, remaining familiar with relevant contractual obligations, sponsor expectations, applicable regulations, and SOPs.
Requirements:
  • Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
  • Previous experience providing knowledge, skills, and abilities to perform the job (comparable to 2+ years).
  • Client-focused approach with strong interpersonal skills, and strong oral and written communication skills and ability to teach others.
  • Strong attention to details and problem-solving skills.
  • Demonstrated competency with Microsoft Office Suite (Word, Excel, PowerPoint, and Project).
  • Positive attitude, enthusiasm toward work, and the ability to work well with others.
  • Effective organization and time management skills with the ability to adapt and adjust to changing priorities and manage multiple assignments with challenging/conflicting deadlines.
  • Solid understanding of clinical trials operational processes and terminology and solid understanding of the software development life cycle (SDLC).
  • Strong troubleshooting skills and ability to analyze software defects, assess the cause of test failures, and explain how errors are produced.
  • Ability to attain, maintain, and apply a working knowledge of GCPs, applicable SOPs/WPDs, and process maps.
  • Ability to review and critique SDLC documentation including requirements, functional design, system design, and test plans.


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