Rho Inc
clinical research
ValidationSpecialistII/III
Neural analysis suggests this role is
optimal for Mid candidates.
“Validation Specialist II / III at Rho Inc. Skills: Validation, Business analysis, Testing, Regulatory compliance. Perform business analysis. Perform validation processes”
What You'll Achieve.
Ensure final outcomes meet specified requirements; Produce high quality documentation to support audits
Industry & Context.
Critical thinker; Evaluate situations objectively; Evaluate opportunities objectively; Craft novel solutions; Craft practical solutions
What They're Looking For.
Must Have
Bachelor's degree or international equivalent, 3 - 5 years of professional work experience in clinical research, Validation experience in GxP environment, Proficiency in validation methodologies, Proficiency in risk-based validation, Proficiency in regulatory expectations, Ability to work as part of a cross-disciplinary team, Ability to communicate and relate to a diverse number of co-workers, Written communication skills, Verbal communication skills, Presentation skills, Attention to detail, Understanding of high-quality scientific standards, Ability to care about every outcome, Honesty, Integrity, Team spirit, Loyalty, Accountability, Mutual trust, Native ingenuity, Ability to change quickly, Ability to adapt and evolve
Nice to Have
Working knowledge of 21 CFR Part 11 regulations, Project management background
What You'll Do.
Perform business analysis
Perform validation processes
Perform testing processes
Support software development
Support software implementation
Direct validation testing
Ensure outcomes meet requirements
Facilitate corporate compliance
Participate in audits
Define and document requirements
Document business processes
Identify project deliverables
Schedule project milestones
Schedule project tasks
Research validation content
Develop validation content
Write validation content
Prepare documentation
Maintain documentation
Create graphical images
Participate in SOP development
Ensure adherence to SOPs
Ensure adherence to regulatory validation
Ensure adherence to quality assurance plans
Act as quality reviewer
Accept quality reviews
Ensure documents meet project requirements
Ensure documents meet SOP requirements
Ensure compliance with testing environment
Create acceptance tests
Execute acceptance tests
Coordinate tester recruitment
Coordinate tester training
Coordinate tester testing
How You'll Work.
Team & Collaboration
Work closely with business primes; Work as part of a cross-disciplinary team; Communicate with co-workers; Relate to co-workers; Contribute to collaborative culture; Work smart together; Work hard together; Laugh together
Communication Scope
Written communication skills; Verbal communication skills; Presentation skills; English fluency; Local languages fluency
Process & Methodology
Identify project deliverables, Schedule project milestones, Schedule project tasks
Full Job Description
The Validation Specialist II / III will perform business analysis, validation, and testing processes required to support the software development and implementation process in the regulated clinical research field. The Validation Specialist II also directs the validation testing of ensuring final outcomes meet specified requirements. Lastly, this position ensures and facilitates corporate compliance with applicable regulations as they affect software development, implementation and maintenance in a regulated environment including participation in audits as they pertain to software projects and systems. Responsibilities * Work closely with business primes to define and document requirements and business processes that drive the features in the software used to support various segments of the clinical trials process * Identify and schedule project deliverables, milestones, and tasks required to validate software releases * Research, develop, and write content for the validation of software products and services * Prepare and maintain documentation and publications relating to users, systems, programming, operations, products, services, testing and validation * Create graphical images, flow charts, and diagrams for inclusion in documentation * Lead and/or participate in developing SOPs (Standard Operating Procedures) that are followed to ensure regulatory compliance in developing or implementing software * Ensure adherence to SOPs, regulatory validation, and quality assurance plans by software developers and their customers * Act as an independent quality reviewer for peer software validations as well as openly accept critical quality reviews of one’s own work with the goal of producing high quality documentation to support audits * Ensure that developed application documents meet all project and SOP requirements * Ensure compliance with testing environment requirements for validation testers * Create and/or execute acceptance tests for software under development and/o
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