GMP Change Control Project Specialist

Katalyst CRO; Vacaville (CA); On-site; USD 70,000 - 110,000; Full time

Job summary

Katalyst CRO is seeking a Project Administrator to support Technology Transfer and CAPEX programs. You will drive Change Control execution, track timelines, and coordinate diverse teams to ensure compliant, timely deliverables.

Applicants should bring hands-on experience with eQMS platforms, strong organizational skills, and the ability to manage multiple priorities in a regulated biopharma environment.

Qualifications

• Bachelor's degree in a life sciences or engineering field is preferred.
• Experience coordinating Change Controls in GMP/regulatory environments.
• Familiarity with eQMS platforms such as Veeva, TrackWise or MasterControl.

Responsibilities

• Own and manage Change Controls for Technology Transfer and CAPEX projects.
• Coordinate cross-functional teams to ensure approvals on schedule.
• Schedule meetings, document minutes, and track action items to closure.
• Maintain audit-ready project records and support regulatory readiness.

Skills

Change Controls

Quality Systems

Stakeholder Mgmt

Project Coordination

Regulatory Awareness

Education

Bachelor's degree (Life Sciences/Engineering/Quality)

Tools

eQMS (Veeva)

TrackWise

MasterControl

Job description

Katalyst CRO is seeking a Project Administrator to support Technology Transfer and CAPEX programs. You will drive Change Control execution, track timelines, and coordinate diverse teams to ensure compliant, timely deliverables.

Applicants should bring hands-on experience with eQMS platforms, strong organizational skills, and the ability to manage multiple priorities in a regulated biopharma environment.