What are the responsibilities and job description for the Project Specialist position at Katalyst CRO?
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.
Responsibilities
Change Control Management:
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 escalate 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.
- 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.
- Quality Assurance
- Compliance / Quality Systems
- Biotech or Pharmaceutical Manufacturing
- Engineering or Validation
- Technology Transfer Support
- Project Administration or Project Coordination
- 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.