Compliance Specialist
Core
Manage change controls, deviations, and CAPA plans within sterile fill finish operations to ensure regulatory compliance and operational efficiency.
Role type
Engineering Compliance Specialist (cGMP)
Builds
Change control documentation, deviation reports, CAPA plans, and SOP updates
Domain
Biopharma / Sterile fill finish manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, root cause analysis, risk assessment, regulatory requirements knowledge, technical writing, cross-functional collaboration
Preferred skills
Bachelor's degree in Science or Engineering, project management
Technologies
None stated
Responsibilities
Initiate and manage change control documentation for equipment and processes; Lead deviation investigations and implement corrective actions; Develop and execute CAPA plans; Collaborate with Quality Assurance and Manufacturing departments
Seniority
Mid-level, hands-on IC
