Project Specialist

Up to $51.70 per hour Vacaville, CA Onsite

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.

• 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.

• 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.

• 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.

• 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, Track Wise, Master Control, 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.

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

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