884 Project Specialist
$79,040–$90,501 year
On-siteVacaville, California, United States
Job Summary
Manage Change Controls supporting Technology Transfer projects from initiation through closure, ensuring timely approvals and compliant execution within a GMP-regulated environment. Drive full lifecycle actions, monitor timelines, identify risks, 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 minutes, track action items, and maintain accurate, audit-ready records. Assist with project reporting, milestone tracking, and stakeholder communications to ensure deliverables are completed on time.
Required Qualifications
- Bachelor's degree in Life Sciences, Biotechnology, Engineering, Quality, Business, or a related discipline
- 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
- 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
- Onsite: Vacaville, CA
Desired Qualifications
- Bachelor's degree in Life Sciences, Biotechnology, Engineering, Quality, Business, or a related discipline preferred
- Experience with electronic Quality Management Systems (eQMS) and Change Control platforms such as Veeva, TrackWise, MasterControl, or similar systems is strongly preferred
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