Alfonso Guarracino

Experience

1. Global Lims Moda System Administrator

   Takeda

   Jul 2025 — Present · Lexington, MA, US

   System Administration- Configure and maintain LabWare LIMS and MODA MES systems, including master data, workflows, and user roles- Manage system interfaces and integrations with laboratory instruments and enterprise platforms- Coordinate change requests and system updates in collaboration with global system owners- End-User Support- Provide technical support and troubleshooting for system users across laboratory and manufacturing teams- Deliver training and documentation to ensure effective system usage and adoption- Compliance & Quality- Ensure systems operate in alignment with Takeda policies, cGMP standards, and regulatory requirements- Support audits and inspections by maintaining accurate system records and documentation- Cross-Functional Collaboration- Work closely with Quality Systems Experts, IT, and manufacturing teams to align system functionality with operational needs- Act as a liaison between local and global stakeholders to ensure consistent system performance and governance.

Education

• Clark University

  Computer Science

Skills

• Quality Assurance
• U.s. Title 21 Cfr Part 11 Regulation
• Cleaning Validation
• Software Documentation
• Root Cause Analysis
• Manufacturing
• Biotechnology
• Process Engineering
• Lean Manufacturing
• Continuous Improvement
• Quality Control
• Gmp
• Computer System Validation
• Pharmaceutics
• Change Control
• Technology Transfer
• Cross-Functional Team Leadership
• Hplc
• Pharmaceutical Industry
• Sop
• Fda
• 21 Cfr Part 11
• Standard Operating Procedure (Sop)
• Life Sciences
• Gamp
• Regulatory Affairs
• Lifesciences
• Validation
• Medical Devices
• Capa
• Regulatory Submissions
• Six Sigma
• Gxp
• Quality Auditing
• Aseptic Processing
• Quality System
• V&V
• Regulatory Requirements
• Process Simulation
• Biopharmaceuticals