Validation Specialist
4 weeks ago
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.
- 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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Validation Specialist
4 weeks ago
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Middleton, Wisconsin, United States Intellectt Inc Full timeJob Title: Validation AnalystAt 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...
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