Génesis A Varela Borrero

• Lead QC operations in a Biosafety Level II (BSL-II) environment for finished product release, performing microbiological, chemical, and physical tests, ensuring compliance with regulatory standards (FDA, ISO 13485).
• Oversee the product stability laboratory program, coordinating stability test points, scheduling, and results communication for blood culture products, ensuring timely data delivery for regulatory submissions.
• Support Out of Specification (OOS) and Quality Notification (QN) investigations, identifying root causes, documenting corrective actions, and implementing process improvements to reduce rework.
• Actively participate in continuous improvement initiatives, including Kaizen activities, lean meetings, and safety audits, driving process efficiency and workplace safety.
• Trained and mentored a team of QC technicians, overseeing their daily tasks, scheduling, and providing on-the-job coaching. Spearheaded training efforts for the technology transfer project to Singapore, conducting virtual and on-site training sessions for QC teams.
• Collaborate with cross-functional teams (QA, engineering, and product support) to support process qualifications, new product launch assessments, and development of new test methods.
• Conduct incoming raw material testing and routine monitoring of the DI Water System, ensuring all materials meet quality standards before use in production.
• Draft and update Standard Operating Procedures (SOPs), QC records, and test methods, ensuring alignment with industry best practices and regulatory requirements.

• Managed the blood donor database, including scheduling, billing, and tracking of donations required for QC testing.
• Performed phlebotomy as a certified technician, ensuring high standards of care and safety during blood draws.
• Assisted principal investigators during internal audits to ensure compliance with regulatory requirements.