Position: IT Validation Lead

100% remote work

Duration: 12 months Contract

Can be 100% remote (in US only).

Summary:

The candidate responsibilities include mainly writing, executing test cases based on functional specifications and managing the validation/test phase to ensure the system release functions as expected by XXX's. The candidate should:

1. Demonstrate attention to detail and accountability.
2. Be responsible for assuring a system/application meets its requirements as outlined in system specification per process defined in the ValidationPlan for the project.
3. Identify and escalate, as necessary project risks and issues to the Project Manager.
4. Be able to prepare reports on defects and problems that arise during system testing.
5. Have solid oral and written communication skills and teamwork skills.
6. Be a good team player, able to meet deadlines and handle changing priorities.
7. Have strong judgment capabilities to clarify requirements when necessary.
8. Have the ability to work with IT management, business analysts and technical staff.
9. Have solid experience working with validated systems
10. Work with business representatives to ensure the test cases reflect business rules and processes
11. Revise test cases as necessary based on project team feedback.
12. Work closely with the Business Analyst to ensure test scripts are ready for OQ and PQ.
13. Other duties include: run validationtest scripts as assigned, assist with preparing and updating validationdocumentation including specifications, defects, etc.
14. As necessary modify/create Qualification Plan, Protocols, Test Plans, Risk Assessments, Reports, Trace Matrix commensurate with project complexity
15. Manage the entire testing phase: validationanalysts, assignments, progress, etc.
16. Develop and execute system test cases, scripts and plans.
17. Understand and follow appropriate SDLC, quality validationprocesses and application processes.
18. Familiar and capable of trace matrix generation
19. Support IT technical and IT validationteams for the development of the functional specifications and the functional testing

Required Qualifications:

1. Minimum BA / BS or relevant work experience in information systems, engineering, science or business.
2. Highly skilled in Computerized System testing and validationin the healthcare industry.
3. The candidate must have experience with HPALM and understand the SDLC processes.
4. Experience with LIMS (LabVanatge) is a highly desired skill set. Additional skills required include developing operational and performance based test scripts from functional specifications.
5. Knowledge of GxP regulations (e.g. 21 CFR Part 11,etc.)
6. Solid project organizational skills. Ability to multi-task. Must have strong analytical problem solving skills.
7. Excellent communication including written, verbal, and listening skills.
8. Self-motivated, detail oriented, takes initiative and ability to work independently without close supervision.

Position: IT Validation Lead 100% remote work Duration: 12 months Contract Can be 100% remote (in US only). Summary: The candidate responsibilities include mainly writing, executing test cases based on functional specifications and managing the validation/test phase to ensure the system release functions as expected by XXX's. The candidate should: 1. Demonstrate attention to detail and accountability. 2. Be responsible for assuring a system/application meets its requirements as outlined in system specification per process defined in the Validation Plan for the project. 3. Identify and escalate, as necessary project risks and issues to the Project Manager. 4. Be able to prepare reports on defects and problems that arise during system testing. 5. Have solid oral and written communication skills and teamwork skills. 6. Be a good team player, able to meet deadlines and handle changing priorities. 7. Have strong judgment capabilities to clarify requirements when necessary. 8. Have the ability to work with IT management, business analysts and technical staff. 9. Have solid experience working with validated systems 10. Work with business representatives to ensure the test cases reflect business rules and processes 11. Revise test cases as necessary based on project team feedback. 12. Work closely with the Business Analyst to ensure test scripts are ready for OQ and PQ. 13. Other duties include: run validation test scripts as assigned, assist with preparing and updating validation documentation including specifications, defects, etc. 14. As necessary modify/create Qualification Plan, Protocols, Test Plans, Risk Assessments, Reports, Trace Matrix commensurate with project complexity 15. Manage the entire testing phase: validation analysts, assignments, progress, etc. 16. Develop and execute system test cases, scripts and plans. 17. Understand and follow appropriate SDLC, quality validation processes and application processes. 18. Familiar and capable of trace matrix generation 19. Support IT technical and IT validation teams for the development of the functional specifications and the functional testing Required Qualifications: 1. Minimum BA / BS or relevant work experience in information systems, engineering, science or business. 2. Highly skilled in Computerized System testing and validation in the healthcare industry. 3. The candidate must have experience with HPALM and understand the SDLC processes. 4. Experience with LIMS (LabVanatge) is a highly desired skill set. Additional skills required include developing operational and performance based test scripts from functional specifications. 5. Knowledge of GxP regulations (e.g. 21 CFR Part 11,etc.) 6. Solid project organizational skills. Ability to multi-task. Must have strong analytical problem solving skills. 7. Excellent communication including written, verbal, and listening skills. 8. Self-motivated, detail oriented, takes initiative and ability to work independently without close supervision.