Project Specialist

Katalyst CRO; Vacaville (CA); On-site; USD 65,000 - 90,000; Full time

Job summary

Katalyst CRO in Vacaville, CA is seeking a Project Administrator to support Technology Transfer and CAPEX projects by managing Change Controls from initiation through closure. You will collaborate with Project Managers and cross-functional teams to ensure changes are executed compliantly, approvals on schedule, and deliverables met in a GMP biopharmaceutical setting.

This role emphasizes timeline management, documentation, and stakeholder communication to drive Change Control execution and

Qualifications

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

Responsibilities

• Own and manage Change Controls across Technology Transfer projects.
• Coordinate with Quality, Manufacturing, Engineering, Validation, Regulatory, and Supply Chain teams.
• Schedule meetings, document minutes, track action items.
• Ensure compliance with cGMP and site procedures; maintain audit-ready records.

Skills

Change Control

Project coordination

GMP

Documentation

Stakeholder management

Education

Bachelor's degree in Life Sciences / Engineering

Tools

Veeva

TrackWise

MasterControl

Job description

Job Description

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.

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.

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 escalat? Wait.
• 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.

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

Requirements

• Bachelor's degree in Life Sciences, Biotechnology, Engineering, Quality, Business, or a 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 such as Veeva, TrackWise, MasterControl, or similar systems is strongly preferred.