Project Specialist

TalentBurst, an Inc 5000 company; Vacaville (CA); On-site; USD 34,440 - 52,348; Full time

Job summary

TalentBurst is seeking a Project Administrator in Vacaville, CA, a 6‑month engagement with possible extension, to support Technology Transfer and CAPEX projects. You will manage Change Controls from initiation through closure and coordinate cross‑functional teams to ensure compliant changes are approved on schedule and project deliverables meet timelines.

The role requires at least 2 years in GMP environments, experience with eQMS platforms, and strong organizational skills to drive timelines

Qualifications

• Bachelor's degree in Life Sciences, Biotechnology, Engineering, Quality, Business, or related discipline preferred.
• 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 (Veeva/TrackWise/MasterControl) preferred.

Responsibilities

• Own and manage Change Controls supporting Technology Transfer projects.
• Drive Change Controls through full lifecycle with timely actions, approvals, and implementation.
• Monitor timelines, identify risks, and escalate issues as needed.
• Coordinate with Quality, Manufacturing, Engineering, Validation, Regulatory, and Supply Chain teams.
• Schedule and facilitate project meetings, document minutes, and track actions to completion.
• Support Project Managers with planning, status tracking, and cross-functional coordination.
• Maintain project documentation and provide regular updates on Change Control status.
• Assist with reporting, milestone tracking, and stakeholder communications.
• Ensure Change Controls and project documentation comply with site procedures and cGMP requirements.
• Maintain audit-ready records and support inspection readiness and regulatory compliance activities.

Skills

Change Control

Project Coordination

GMP Compliance

Education

Bachelor's degree in Life Sciences

Tools

Veeva

TrackWise

MasterControl

Job description

Title: Project Administrator

Duration: 6 months with possible extension

Location: VacavilleCA 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 upscale 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.

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.