Change Control Specialist
Core
Develop strategic plans for change control and implement robust corrective actions to support manufacturing operations.
Role type
Change Control Specialist
Builds
Manufacturing operations support via Corrective and Preventative Actions (CAPAs) and process improvements
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Change control planning, CAPA implementation, risk assessment, cGMP documentation review, cross-functional coordination, project monitoring, regulatory impact analysis, training delivery
Preferred skills
Mentorship of cross-functional teams, senior leadership presentation
Technologies
cGMP standards, CAPA systems
Responsibilities
Craft business plans to advance change control initiatives, assess proposed change controls against company standards, coordinate change control documentation, review and revise controlled documentation, lead cross-functional meetings, monitor and progress multiple projects, present change controls to senior leadership, document and assist with employee training
Seniority
Mid-level to Senior, hands-on IC