Validation Business Analyst- Remote
Validation Business Analyst- Remote
Posted on :
03-11-2024
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Job Description
For further inquiries regarding the following opportunity please contact our Talent Specialist:
Infant at
Infant at
Title: Validation Business Analyst Remote
Location: Remote
Duration: 12 Months with possible extension
Location: Remote
Duration: 12 Months with possible extension
Job Description :
Purpose of the Role & Key Requirements:
- The primary objective of this role is to support the upgrade of the current Quality Management System (QMS) to the latest vendor version.
- This Business Analyst will focus on documentation coordinating the software upgrade and gathering feedback for User Acceptance Testing (UAT) to prepare for verification testing.
- Although direct testing is not part of the role the Business Analyst will work closely with business stakeholders to collect UAT feedback raise questions and ensure issues are addressed within project timelines.
- This role requires a professional capable of collaborating effectively with small project teams including IT and Business Partners.
Work Schedule:
- Regular business hours mf with some flexibility to work with global teams infrequently but as needed.
- Project Upgrade current software of the existing application.
Top 35 Must Have Nonnegotiable Skills Required:
1. Experience working in Computer System Validation (CSV) Documentation; Functional and Technical
2. Experience working with business stakeholders to aid them in user testing acceptance
3. Knowledge and/or Experience with Trackwise or other Quality Management Systems
4. Must be professional assertive articulate and collaborative
5. Attention to detail accuracy and timelines.
1. Experience working in Computer System Validation (CSV) Documentation; Functional and Technical
2. Experience working with business stakeholders to aid them in user testing acceptance
3. Knowledge and/or Experience with Trackwise or other Quality Management Systems
4. Must be professional assertive articulate and collaborative
5. Attention to detail accuracy and timelines.
6. Years if required Experience: 5 years.
Is a Bachelors Degree Required NO
How many years of recent experience does this person need to have 5 years
Medical Devices Industry Experience: Preferred
Nice to Have Skills:
1. Knowledge of ALM application for test cases
2.Experience with drafting dry running and executing test cases
1. Knowledge of ALM application for test cases
2.Experience with drafting dry running and executing test cases
This section focuses on the main purpose of the job in one to four sentences. Identify evaluate develop and/or update TrackWise QMS related validation package documentation to support project needs. Provide consultation to Quality business partners on TrackWise related changes associated with the upgrade project. Assist in the development of system and testing documentation and training materials as needed.
This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work. The incumbent will own key tasks demonstrate solid knowledge of validated systems and computer system validation require moderate direction give minimal guidance to others handle moderately complex problems possess solid knowledge of SDLC
1. Gather understand and document technical objectives specifications and requirements on TrackWise platform upgrade project.
2. Develop and execute unit/system test cases scripts and plans.
3. Define design and document business flows and related documentation.
Top Skills Required:
Experience in Computer System Validation (CSV) including functional or technical documentation
Expertise in collaborating with business stakeholders for User Acceptance Testing
Proficiency with TrackWise
Knowledge of ALM (preferred)
Experience in Computer System Validation (CSV) including functional or technical documentation
Expertise in collaborating with business stakeholders for User Acceptance Testing
Proficiency with TrackWise
Knowledge of ALM (preferred)
Interview process: (Teams/Onsite Length Rounds Team involved) 2 rounds 1st with the manager 2nd with a BA on the team
Interview Process: 2 rounds (Teams interview)
Travel Involved No
About us: DivIHN the IT Asset Performance Services organization provides Professional Consulting Custom Projects and Professional Resource Augmentation services to clients in the MidWest and beyond. The strategic characteristics of the organization are Standardization Specialization and Collaboration. DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race color religion (creed) gender gender expression age national origin (ancestry) disability marital status sexual orientation or military status.
Employment Type
Full Time
Key Skills
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