KH
Project Specialist
Katalyst Healthcares & Life Sciences
- 🇺🇸 United States
- On-site
- Manager or above
- 3 hours ago
- GMP
- Veeva
- Regulatory Compliance
3 hours ago
We are seeking a detail-oriented Project Specialist to support Technology Transfer and CAPEX projects within a GMP-regulated biopharmaceutical environment. The role is responsible for coordinating and managing Change Controls from initiation through closure, tracking project timelines, obtaining required approvals, and ensuring compliance with cGMP requirements and site procedures. The ideal candidate will collaborate with cross-functional teams, including Quality, Manufacturing, Engineering, Validation, Regulatory, and Supply Chain, to drive action items, maintain accurate documentation, monitor project milestones, and ensure timely project execution. Experience with electronic Quality Management Systems (eQMS), such as Veeva, TrackWise, or MasterControl, is highly preferred.
Roles & Responsibilities:
- Manage and coordinate Change Controls for Technology Transfer and CAPEX projects from initiation through closure.
- Track Change Control activities, ensuring timely completion of action items, approvals, and implementation milestones.
- Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, Engineering, Validation, Regulatory, and Supply Chain, to support project execution.
- Monitor project schedules, milestones, and deliverables; identify potential delays or risks and escalate issues to the appropriate stakeholders.
- Support Project Managers with project planning, progress tracking, reporting, and stakeholder communication.
- Schedule and facilitate project meetings, prepare meeting minutes, and follow up on action items to ensure timely completion.
- Maintain accurate, complete, and audit-ready project documentation and Change Control records in accordance with site procedures and cGMP requirements.
- Utilize electronic Quality Management Systems (eQMS), such as Veeva, TrackWise, MasterControl, or similar platforms, to track and manage Change Controls.
- Ensure required documentation, reviews, and approvals are completed in accordance with established quality systems and regulatory requirements.
- Support inspection readiness, compliance activities, and documentation reviews within a GMP-regulated biopharmaceutical environment.
- Coordinate with stakeholders to resolve outstanding issues, maintain project timelines, and ensure successful implementation of approved changes.
- Provide regular status updates on Change Controls, project progress, risks, and outstanding deliverables to project leadership and relevant stakeholders.
- Manage multiple priorities simultaneously while maintaining strong attention to detail, documentation accuracy, and compliance standards.
- Bachelor's degree in Life Sciences, Biotechnology, Engineering, Quality, Business Administration, or a related discipline preferred.
- Minimum of 2 years of experience in biotechnology, pharmaceutical, medical device, or other GMP-regulated industries.
- Experience coordinating or managing Change Controls within a regulated manufacturing or quality environment.
- Working knowledge of cGMP requirements, quality systems, controlled documentation, and regulatory compliance.
- Experience supporting Technology Transfer, CAPEX projects, Quality Assurance, Validation, Engineering, or project coordination activities is preferred.
- Hands-on experience with electronic Quality Management Systems (eQMS), such as Veeva, TrackWise, MasterControl, or similar Change Control platforms, is strongly preferred.
- Demonstrated ability to coordinate cross-functional teams, manage project timelines, track action items, and ensure timely completion of deliverables.
- Strong organizational, communication, documentation, and stakeholder management skills, with excellent attention to detail.
Project Specialist · Katalyst Healthcares & Life Sciences