What are the responsibilities and job description for the Professional - Sr Project Specialist position at TalentBurst, an Inc 5000 company?
Title: Sr Project Specialist
Location: Las Vegas, NV (Remote)
Duration: 8 months
Position Summary
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.
Key Responsibilities
• 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).
Qualifications
Education & Experience
• 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.
Skills & Competencies
• 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.
Additional Information
Occasional travel may be required for workshops, training, or system validation activities. Hybrid or remote work arrangements may be available depending on project needs.Additional Job Details:We are considering this role as "near site” which means they need to be within driving distance to a major location (preference to Wood Dale, IL). They can work remotely, but need to be close in order to pick up/drop off PC, troubleshoot issues with local IT, etc.
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Why TalentBurst?
At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.
Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.
We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.
TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.