San Juan, Puerto Rico
For more than 25 years, I've worked behind the scenes of the pharmaceutical industry — the part most people never see. As a Quality Assurance and Validation consultant, I've helped some of the world's largest pharma and medical device companies meet the standards that keep their products safe: Pfizer, Johnson & Johnson, GSK, AstraZeneca, Roche, Baxter, and many others. I've contributed to certified compounding cleanrooms to ISO 7. I've led the remediation of 300 FDA audit findings. I've led a pharmaceutical manufacturing operation through a crisis. I'm Six Sigma Black Belt certified by GE, and I know USP 797 — the standard that governs pharmaceutical compounding — not from a textbook, but from doing the work. Today, I'm bringing that experience to a field that urgently needs it: longevity medicine. The market for peptides, hormones, and longevity compounds is exploding — and it's flooded with products that have none of the quality and regulatory rigor I spent my career enforcing. Cheap PDFs and slick marketing tell healthcare professionals what to use. Almost no one tells them how to judge whether what they're prescribing was made right. That's the gap I help close. I work with physicians, nurse practitioners, PAs, and compounding pharmacies who want to operate in this space the right way — with real quality standards, defensible compliance, and the confidence that comes from understanding what's behind the vial. I don't replace your clinical judgment; I sharpen it with the quality and regulatory perspective that the industry's biggest players rely on. If you're a healthcare professional entering longevity medicine and you want to do it with rigor instead of guesswork, follow along. I share what I see — and what you should be asking — here.
Project Manager for: • SK-Biotechnologies, Philadelphia • Janssen Johnson and Johnson, Project Manager, Huejotzingo Puebla, Mexico • Santa Cruz Nutritionals, Engineering Support Project, CA • Noven Pharmaceuticals, CSV Support, Miami FL • Johnson and Johnson Quality Assurance Support Project, Colorado • Johnson and Johnson Operational Optimization Project, Colorado • ERP Computer System Validation Life Cycle Implementation for Drogueria Betances Pharmaceutical Distribution Center, Caguas • ERP Computer System Validation Life Cycle for LGI Pharmaceutical Distribution Center, Bayamon • Design, developed, implement and validate a customized Temperature Monitoring System Application for Pharma product cooler, for Drogueria Betances • Baxter Compounding Center Regulatory and Operational Improvements Project • Pall Corporation, Clean Room Equipment Qualification, and Laboratory Validation Projects
Developed Productivity Projects for a Health Care Facilities: By improving service, without affecting compliance. Lead the project for creating a new medical transportation company that complies with the Good Storage and Transportation Practices requirements set by the USP 787 and USP 1079.
Validation Project Manager for Baxter Healthcare Facility , Guaynabo, PR Compounding Center Validation Project -Responsible for completing the final certification of the Compounding Cleanroom as Class 10,000 (ISO 7). The project included Environmental Monitoring, Equipment, Computer Validation, Facility and Utilities Qualification, Cleaning Validation, Preventive Maintenance procedures and support. The Equipment included Laminar Flow Hood, Freezer, and Incubators. Computer Validation included the Baxa Excatamix Compounder System, and the Rees Scientific Environmental Monitoring System. Utilities included four (4) Air Handling Units with their ancillary equipment Chillers and Dehumidifier. The Facility Qualification included the verification of the construction phase by phase, including: materials used, installed doors, view panels, illumination, fire system, Clean room measurements against Baxter’s Specifications and Requirements. All procedures affected were verified and submitted for changes. Support Preventive Maintenance program. Environmental monitoring Qualification included the Clean Room certification as an ISO 7, and the ante areas for ISO 8 certification. Documents prepared covered: Project Master Plan, User Requirements, Specifications, Commissioning, Design Verification, Installation Qualification, Operational Qualifications and Performance Qualification protocols. Cleaning Validation Protocols, Environmental Monitoring and Computer Validation Life Cycle.
Confidential.
Support Conmar Management Team solving CAPAs, Non-Comformances, Customers complaints, and audits outcomes.