Project Specialist

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.

Key Responsibilities:
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 escalate issues as needed.

· Coordinate with Quality, Manufacturing, Engineering, Validation, Regulatory, and Supply Chain teams to support successful change implementation.

2. 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.

3. 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 managing or coordinating Change Controls in a complex regulated environment.

· 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.

· Familiarity with cGMP requirements and regulated manufacturing environments.

· Excellent organizational, communication, and stakeholder management skills.

· Ability to manage multiple priorities and drive actions to completion across cross-functional teams.

· 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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