Cristhian E. Bautista
Quality Assurance (Qa) Specialist - Individualized Neoantigen Therapy (Int) (Cancer Treatment) @Moderna
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WORK HISTORY
Quality Assurance (Qa) Specialist - Individualized Neoantigen Therapy (Int) (Cancer Treatment) @Moderna
Description:I provide oversight of manufacturing activities and Facilities at Moderna Inc.• Provide quality supervision/support of manufacturing, reviewing documentation, and providing real-time support of manufacturing issues• Support quality decisions that may impact operations, ensuring appropriate escalation.• Identify risks and communicate gaps for quality and GMP process/systems.• Supports, reviews and approves Deviations and change controls• Create Corrective Actions and Preventive Actions (CAPA) to mitigate future deviations • Authors and reviews SOPs, policies to ensure compliance and adherence to regulations/cGMP operations.• Collaborate with Manufacturing to resolve equipment and process issues• Support internal audits.• Review batch records for GDP / GMP and accuracy • Practice safe work habits and adhere to Moderna’s safety procedures and guidelines• Automated data processing and analysis using Moderna\'s AI toolsWriting full investigations and Deviation Reports (DR) and Leading high-level risk investigation per protocol and GMP guidelines• Writing Deviation/Incident Investigations • Performing Root Cause Analysis (RCA) for all criticality deviation levels
EDUCATION
Kean University
Bachelor of Science (B.S.) in Molecular Biology, Cell & Molecular Biology
SKILLS
ABOUT CRISTHIAN E. BAUTISTA
Top-performing Pharmaceutical Quality expert with experience in Tissue, Cell, and Gene Therapy. My skills include good laboratory practice (GLP), good manufacturing practice (GMP), document management and good documentation practices (GDP), management of analytical data, remediation and prevention plans, Process Improvement, managing change controls, and CAPA mitigation. I thrive in dynamic environments and quickly adapt to the ever-changing demands of the pharmaceutical field. I am detail-oriented, conscientious, and organized. I am an effective and strong communicator, a person who brings a positive attitude to the work environment, and a professional who never backs down from a challenge.
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