Project Specialist

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.

 

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Preferred Background

 

· Quality Assurance

 

· Compliance / Quality Systems

 

· Biotech or Pharmaceutical Manufacturing

 

· Engineering or Validation

 

· Technology Transfer Support

 

· Project Administration or Project Coordination

 

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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.

Job Sumary:
Project Administrator

Shift: ['Change Control Management', 'Communication', 'GMP Compliance']

Start: ['Biotechnology', 'GMP Operations', 'Project Management']

EEO:
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”