
Detail-oriented medical device manufacturing professional with hands-on experience in GMP-regulated cleanroom environments and contamination-controlled production settings. Strong background in SOP adherence, quality documentation, equipment sanitation, and regulated material handling.
• Perform production of implantable bone graft materials in ISO/GMP cleanroom environments with strict contamination control standards.
• Follow detailed written procedures to ensure compliance with regulatory and quality requirements.
• Maintain accurate batch records to ensure traceability of regulated medical device components.
• Prepare and handle chemical solutions in accordance with safety protocols.
• Support sterile handling procedures prior to final packaging and lyophilization.
• Maintained GMP cleanroom compliance within pharmaceutical manufacturing operations.
• Monitored controlled environments to ensure adherence to contamination prevention standards.
• Assisted in training personnel on cleanroom best practices and safety procedures.
• Managed regulated materials within GMP production environments. • Ensured proper labeling, storage, and traceability of controlled medical materials.
• Conducted inspections of incoming materials to verify quality and documentation accuracy.
• Advanced experience with inventory & tracking systems (QAD)
Regulatory Compliance Mindset
Detail-Oriented Quality Assurance
Controlled Environment Awareness
Safety & Hazard Mitigation
Process Accuracy & Accountability
Documentation Integrity
Time Management in Regulated Settings
Inventory & Tracking Software Proficiency
Cross-Functional Team Collaboration
Forklift Certified