Project Specialist

TalentBurst; Vacaville (CA); On-site; USD 65,000 - 95,000; Part time

Benefits offered by this job

Medical, dental, vision

Retirement options

Competitive compensation

Job summary

TalentBurst is hiring a Project Administrator to support Technology Transfer and CAPEX initiatives at a GMP-regulated biopharma site in Vacaville, CA. The role centers on leading Change Controls from initiation to closure, coordinating multi-disciplinary teams, and maintaining audit-ready records.

Requires 2+ years in biotech/pharma or GMP settings, with experience in eQMSs like Veeva, TrackWise, or MasterControl. This 6-month assignment emphasizes compliance, timelines, and project execution.

Qualifications

• Bachelor's degree in Life Sciences, Biotechnology, Engineering or related field.
• 2+ years in biotechnology, pharma, or GMP-regulated industry.
• Experience coordinating Change Controls in a complex regulated setting.
• Familiarity with eQMS platforms (Veeva/TrackWise/MasterControl) preferred.

Responsibilities

• Own and manage Change Controls for Technology Transfer projects.
• Drive Change Controls through full lifecycle with timely approvals.
• Coordinate cross-functional teams and document actions and milestones.
• Ensure compliant records and audit-ready documentation.

Skills

Change Control

Project coordination

Stakeholder management

Documentation accuracy

Education

Bachelor's degree

Tools

Veeva

TrackWise

MasterControl

Job description

Title: Project Administrator
Duration: 6 months with possible extension
Location: Vacaville CA 95688
Interview Process: 1st Phone with Manager, 2nd Panel, In-Person

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 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 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

Quick Summary (for Hiring Use)

Focus: Change Control management, coordination, and execution.
Core Role: Own Change Controls, drive timelines, coordinate stakeholders, and support Technology Transfer project execution.
Environment: GMP / Biopharmaceutical Manufacturing.
Preferred Experience: Biotech or pharmaceutical industry experience with electronic Change Control and Quality Management Systems in a regulated, complex operating environment.

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Why TalentBurst?

At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

• We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.