Job Description
Job Description
JOB DESCRIPTION
Project Administrator – Job Description
Duration: 6 months with possible extension
Interview Process: 1st Phone with Manager, 2nd Panel, In-Person
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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.
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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.
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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.