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Job Requirements of Sr Project Specialist:
-
Employment Type:
Contractor
-
Location:
Las Vegas, NV (Onsite)
Do you meet the requirements for this job?
Sr Project Specialist
Careers Integrated Resources Inc
Las Vegas, NV (Onsite)
Contractor
Job Title: Senior Project Specialist (Quality Systems / CSV)
Job Location: Las Vegas, NV (Hybrid)
Job Duration: 6+ Months
Shift: Day shift.
Pay Rate: $95.00 – $105.00/hr. on W2
Additional Information:
Occasional travel required (workshops, validation activities)
Hybrid/remote flexibility based on project needs
Overview:
We are seeking a Senior Project Specialist to support the delivery of technology initiatives within Quality and Regulatory Affairs. This role acts as a critical bridge between business stakeholders and technical teams, ensuring system implementations, enhancements, and automations meet compliance, quality, and user requirements in a regulated environment.
Project Execution & Validation:
Training & Change Management:
Business & Technical Support:
Education: Bachelor’s degree in Life Sciences, Engineering, Information Systems, or related field
Experience:
Technical Skills:
Core Competencies:
Job Location: Las Vegas, NV (Hybrid)
Job Duration: 6+ Months
Shift: Day shift.
Pay Rate: $95.00 – $105.00/hr. on W2
Additional Information:
Occasional travel required (workshops, validation activities)
Hybrid/remote flexibility based on project needs
Overview:
We are seeking a Senior Project Specialist to support the delivery of technology initiatives within Quality and Regulatory Affairs. This role acts as a critical bridge between business stakeholders and technical teams, ensuring system implementations, enhancements, and automations meet compliance, quality, and user requirements in a regulated environment.
Project Execution & Validation:
- Develop, review, and execute validation documentation (IQ, OQ, PQ).
- Support and document User Acceptance Testing (UAT).
- Assist in data migration, transformation, and validation activities.
- Review system interfaces, business requirements, and technical specifications.
Training & Change Management:
- Create and deliver end-user training (eLearning, workshops, demos).
- Develop materials for Conference Room Pilots (CRPs).
- Author and maintain SOPs, work instructions, and user guides.
Business & Technical Support:
- Translate business needs into technical requirements and test scenarios.
- Support post-deployment data verification and issue resolution.
- Ensure compliance with regulatory standards (GxP, 21 CFR Part 11).
Education: Bachelor’s degree in Life Sciences, Engineering, Information Systems, or related field
Experience:
- 5+ years in Quality, Regulatory, or IT project support.
- Experience in life sciences / pharma / medical device environments.
- Strong experience with Computer System Validation (CSV).
- Experience working in GxP-regulated systems.
Technical Skills:
- Validation documentation (IQ/OQ/PQ, UAT).
- Familiarity with systems such as ERP, eQMS, LIMS, or RIM.
- Strong documentation and compliance experience.
- Tools: Microsoft Office, SharePoint, Smartsheet, JIRA, Teams.
Core Competencies:
- Strong understanding of regulatory and quality frameworks.
- Excellent communication and stakeholder management skills.
- Detail-oriented with strong organizational abilities.
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