New

Professional - Sr Project Specialist

Spectraforce Technologies
remote work
United States, Nevada, Las Vegas
Apr 07, 2026
Title- Professional - Sr Project Specialist Location- Las Vegas NV 89119 Duration- 8 months Shift- Multiple with Eastern as the primary Job Description: 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.