Bachelor's degree in Life Sciences, Engineering, Information Systems, or a related field
5+ years of experience in Quality, Regulatory, or IT project support roles in a life sciences or medical device environment
Experience with computer system validation (CSV) and GxP-compliant systems
Familiarity with ERP, eQMS, LIMS, or RIM systems
Requirements:
Support planning, execution, and delivery of technology projects within Quality and Regulatory Affairs, ensuring systems meet compliance and user needs
Author and execute validation deliverables (IQ, OQ, PQ), participate in user acceptance testing (UAT), and assist with data migration/ transformation logic
Develop end-user training materials (eLearning, classroom), create workshop materials for conference room pilots, and maintain SOPs and system user guides
Translate business needs into technical requirements with process owners, support data verification post-deployment, and maintain compliance with 21 CFR Part 11 and GxP
Job description
Our Client, a Medical Research company, is looking for a Senior Project Specialist for their Las Vegas, NV/ Hybrid /Remote location.
Responsibilities:
The Senior Project Specialist supports the planning, execution, and delivery of technology projects within the Quality and Regulatory Affairs organization.
This role bridges the gap between business users and technical teams, ensuring that system implementations, upgrades, and process automations meet compliance, quality, and user needs.
The individual will play a key role in authoring and executing validation documentation, supporting training and user readiness, and performing data and interface verification throughout the project lifecycle.
Project Execution & Validation
Develop, review, and execute validation deliverables such as IQ, OQ, and PQ protocols.
Participate in and document User Acceptance Testing (UAT) activities.
Support authoring and execution of data migration and transformation logic.
Review system interfaces, business requirements, and technical specifications.
Training & Change Management
Assist in the development and delivery of end-user training materials, including eLearning content, classroom materials, and live demonstrations.
Create workshop and presentation materials for conference room pilots (CRPs).
Author and maintain SOPs, work instructions, and system user guides.
Business & Technical Support
Collaborate with business process owners to translate business needs into technical requirements and testable solutions.
Support data verification activities post-deployment.
Maintain compliance with corporate and regulatory standards (e.g., 21 CFR Part 11, GxP, etc).
Requirements:
Bachelor’s degree in Life Sciences, Engineering, Information Systems, or a related field required.
5+ years of experience in Quality, Regulatory, or IT project support roles in a life sciences or medical device environment.
Experience with computer system validation (CSV) and GxP-compliant systems required.
Familiarity with ERP, eQMS, LIMS, or RIM systems preferred.
Strong understanding of quality system principles and regulatory compliance.
Ability to author technical documentation and validation deliverables.
Proficient in Microsoft Office, SharePoint, and project collaboration tools (e.g., Smartsheet, Teams, JIRA).
ICONMA is an Equal Opportunity Employer. All qualified applicants will receive considerationfor employment without regard to any status protected by applicable law.
