Job Details

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).
• Excellent communication and organization skills.

Why Should You Apply?

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities

ICONMA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to any status protected by applicable law.