Compliance Officer (Inspection Coordinator)
Core
Implement and maintain internal audit systems to ensure manufacturing facility operations comply with regulations and standards.
Role type
Compliance Officer (Inspection Coordinator)
Builds
Internal audit systems and regulatory compliance frameworks for manufacturing operations
Domain
Biopharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory compliance auditing, FDA/DEA inspection coordination, CAPA management, GMP evaluation, process metrics analysis, quality improvement project coordination
Preferred skills
Science or Engineering degree background, extensive plant-level procedure knowledge
Technologies
CFR, MCA, DEA regulations
Responsibilities
Plan and conduct internal compliance audits, serve as plant administrator for regulatory agency inspections, convey violations to management via reports, follow up on audit action plans, disseminate regulatory requirements to personnel, manage manufacturing materials and pest control programs, coordinate quality improvement projects, perform metrics collection and analysis for corrective actions
Seniority
Mid-level, hands-on IC
