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Sr Validation Analyst

  • Location: Madison
  • Type: Direct Hire
  • Job #3079

Carex is working with a leading global research organization focused on delivering life changing therapies.  We are helping them locate a Sr. Validation Analyst.  This role provides advanced business/system support of software systems and/or laboratory instrumentation. Collaborates with staff of various departments and the client to initiate and complete performance qualification (PQ) validation activities. Manages the validation process as well as implementation of system upgrades, including guiding, testing, and supporting the introduction, as well as ongoing support of software systems. Assists management with maintaining project schedules and providing estimated levels of effort for validation tasks.

What you’ll do:

  • Participates as a member of project teams and helps provide direction on future enhancements to the system. Communicates proactively with all project team members and provides regular feedback to management concerning timeline/budget or resource constraints.
  • Provides comprehensive validation support for new releases and modifications to applications throughout the software development life cycle. Prepares validation plans, test cases, and validation summary reports, and executes test cases.
  • Reviews and approves change controls associated with the validated systems per SOP. Ensures test scripts challenge the functional requirements and adequately demonstrate that the application meets the expectations of the business customer.
  • Executes test scripts accurately to produce evidence that the computer system consistently performs its intended functions accurately and reliably. Creates, updates, and manages sufficient data within the testing environment to accurately test software functionality. Works with leadership to address any PQ related issues arising from client or internal audits.
  • Cross-trains and mentors team members on systems of expertise. May assign, monitor, and review progress and accuracy of the work of junior team members, directing efforts appropriately and providing technical guidance on more complex issues. Trains personnel resourced to validate software releases, including internal testers, contractors, and temporary employees.
  • Remains familiar with relevant contractual obligations, sponsor expectations, applicable regulations, and SOPs.
  • Participates in departmental and corporate process initiatives.
  • Prepares for and represents departments within relevant system-related client/audit forums as well as through sponsor audits. Participates in or conducts vendor audits as appropriate for tools or systems in use.

What you’ll bring:

  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
  • Demonstrated client-focused approach with strong interpersonal skills, excellent oral and written communication skills, and ability to teach others.
  • Excellent attention to detail and problem-solving skills.
  • Demonstrated skills with Microsoft Office Suite (Word, Excel, PowerPoint, and Project). Proven ability to learn new computer software with minimum of instruction.
  • Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others.
  • Excellent organization and time management skills with the ability to adapt and adjust to changing priorities and manage multiple assignments with challenging/conflicting deadlines, meeting timelines and negotiating schedule changes in response to project demands.
  • Solid understanding of clinical trials operational processes and terminology and thorough understanding of the software development life cycle (SDLC).
  • Demonstrated ability to identify and resolve technical problems in a professional environment, to include excellent troubleshooting skills and ability to analyze software defects, assess the cause of test failures, and explain how errors are produced.
  • Effective ability to attain, maintain, and apply a working knowledge of GCPs, applicable SOPs, and process maps. Ability to review and critique SDLC documentation including requirements, functional design, system design, and test plans.
  • Demonstrated ability to effectively coordinate project activities, including through the development, negotiation, and maintenance of project schedules and timelines in accordance to project demands on a multi-disciplinary team.
  • Solid knowledge of computer systems validation, applicable regulations, and system testing processes. Ability to realize validation process needs and provide solutions.


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