Project Specialist

Creative Solutions Services, LLC; Vacaville (CA); On-site; USD 66,124 - 71,635; Full time

Job summary

Creative Solutions Services, LLC is seeking a Project Specialist to support Technology Transfer and CAPEX projects in a GMP-regulated biopharmaceutical environment.

You will manage Change Controls from initiation through closure and coordinate cross-functional teams to meet timelines and deliverables.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 2+ years of experience in biotechnology/pharma or GMP-regulated industries.
• Experience managing or coordinating Change Controls in a regulated environment.
• Experience with electronic Quality Management Systems (eQMS) such as Veeva/TrackWise/MasterControl preferred.

Responsibilities

• Own and manage Change Controls across the full lifecycle.
• Coordinate with Quality, Manufacturing, Engineering, Validation, Regulatory, and Supply Chain teams.
• Schedule meetings, document minutes, and track action items to completion.
• Maintain audit-ready project documentation and support regulatory readiness.

Skills

Change Control

Quality Systems

Stakeholder management

Organizational skills

Communication

Education

Bachelor's degree in Life Sciences/ Biotechnology/ Engineering/ Quality/ Business

Tools

eQMS (Veeva, TrackWise, MasterControl)

Job description

Up to $51.70 per hour Vacaville, CA Onsite

Job Description

Role: Project Specialist
Location: 1000 New Horizons Way, Vacaville, CA 95688
Duration:6 months with possible extension or FTE Conversion
Interview Process:1st Phone with Manager, 2nd Panel, In-Person
Pay rate: $50/hr on W2 + Benefits

Job Summary:
The Project Administrator supports Technology Transfer and CAPEX projects by managing and coordinating Change Controls from initiation through closure. This role works closely with Project Managers and cross-functional teams to ensure changes are executed compliantly, approvals are obtained on schedule, and project deliverables are completed on time. The Project Administrator serves as a key driver of Change Control execution, timeline management, and team coordination within a GMP-regulated biopharmaceutical environment.

Change Control Management:

• Own and manage Change Controls supporting Technology Transfer projects.
• Drive Change Controls through the full lifecycle, ensuring timely completion of actions, approvals, and implementation activities.
• Monitor timelines, identify risks or delays, and elevate issues as needed.
• Coordinate with Quality, Manufacturing, Engineering, Validation, Regulatory, and Supply Chain teams to support successful change implementation.

Project Administration & Coordination:

• Schedule and facilitate project meetings, document meeting minutes, and track action items to completion.
• Support Project Managers with project planning, status tracking, and cross-functional coordination.
• Maintain project documentation and provide regular updates on project and Change Control status.
• Assist with project reporting, milestone tracking, and stakeholder communications.

Compliance & Execution:

• Ensure Change Controls and project documentation comply with site procedures and cGMP requirements.
• Maintain accurate, complete, and audit-ready records.
• Support inspection readiness and regulatory compliance activities.
• Drive accountability across stakeholder groups to meet project timelines and business objectives.

Qualifications:

• Education: Bachelor's degree in Life Sciences, Biotechnology, Engineering, Quality, Business, or a related discipline preferred.
• Experience: 2+ years of experience in biotechnology, pharmaceutical, medical device, or other GMP-regulated industries.
• Experience: Experience managing or coordinating Change Controls in a complex regulated environment.
• Experience: Experience with electronic Quality Management Systems (eQMS) and Change Control platforms such as Veeva, TrackWise, MasterControl, or similar systems is strongly preferred.
• Core Competencies: Strong understanding of Change Control processes and quality systems.
• Core Competencies: Familiarity with cGMP requirements and regulated manufacturing environments.
• Core Competencies: Excellent organizational, communication, and stakeholder management skills.
• Core Competencies: Ability to manage multiple priorities and drive actions to completion across cross-functional teams.
• Core Competencies: Strong attention to detail and ability to maintain compliant documentation.

Preferred Background:

• Quality Assurance
• Compliance / Quality Systems
• Biotech or Pharmaceutical Manufacturing
• Engineering or Validation
• Technology Transfer Support
• Project Administration or Project Coordination.

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