IRENE MELÉNDEZ RODRÍGUEZ
Sarasota,FL
Summary
Quality and operations leader with 15+ years of experience in regulated environments including medical devices, sterile compounding, nutraceutical manufacturing, and pharmaceutical operations. Proven ability to own quality systems end-to-end, build and standardize SOPs, lead audit readiness, and partner cross-functionally with operations, engineering, and suppliers. Known for translating regulatory requirements into practical, scalable systems that improve compliance, efficiency, and accountability.
Overview
26
26
years of professional experience
Work History
Quality & Operations Manager (Site Lead)
MitoZen Scientific
Sarasota, FL
05.2020 - 01.2026
- Owned site-level quality systems and operational compliance for a regulated nutraceutical manufacturing operation, overseeing documentation, SOP governance, audit readiness, and cross-departmental workflows. Designed and implemented SOPs, batch records, labeling compliance, traceability controls, and QC checkpoints. Led audit readiness, training programs, vendor qualification, supplier quality, and cross-functional process improvements.
Lead Sterile Compounding Pharmacy Technician
Family Pharmacy
Orlando, FL
01.2015 - 04.2020
- Performed sterile and non-sterile compounding under USP /. Supported compliance audits, sterile certification renewals, calibration programs, environmental monitoring, and batch traceability while training staff.
Sterile Compounding Pharmacy Technician
QMedRx
Orlando, FL
05.2013 - 12.2014
- Executed sterile compounding under USP with responsibility for sterile logs, environmental monitoring records, calibration coordination, and audit documentation.
Pharmacy Technician
Sam’s Club Pharmacy
Orlando, FL
01.2006 - 04.2013
- Managed prescriptions, controlled substances, inventory controls, and insurance/Medicaid compliance. Improved workflow efficiency and trained staff on compliant pharmacy operations.
Quality Technician → Manufacturing Technician
CooperVision
Juana Díaz, PR
07.2000 - 12.2005
- Supported medical device quality operations under FDA and ISO 13485 frameworks. Performed inspection, microbiology testing, environmental monitoring, traceability, and collaborated on IQ/OQ/PQ validation activities.
Education
Bachelor of Science - Chemistry
University of Puerto Rico
Ponce, PRAssociate of Science - Pharmacy Technology
Paramedical College
Ponce, PREnglish for Academic Purposes & Pre-Pharmacy Coursework
Valencia College / University of Central Florida
Orlando, FLSkills
Global & Site-Level Quality Systems Ownership (QMS)
SOP Governance & Documentation Lifecycle
Audit Readiness & Regulatory Inspections (FDA, ISO-aligned)
CAPA, Deviations, Change Control & Root Cause Analysis
Cross-Functional Leadership (Operations, Supply Chain, Engineering)
Supplier & Vendor Quality Management
Training Programs & Quality Culture Development
Continuous Improvement & Quality KPIs
Batch Records, Traceability & Data Integrity
Risk Assessments & Compliance Strategy
QMS Documentation Systems
SOP & Work Instruction Management
CAPA & NCR Tracking
Batch Record Systems
Audit & Inspection Support
Environmental Monitoring
Calibration Coordination
Training Records
Vendor Quality Controls
USP /
FDA & ISO-Aligned Quality Frameworks
Languages
Spanish (Native)
English (Fluent)
Timeline
Quality & Operations Manager (Site Lead)
MitoZen Scientific
05.2020 - 01.2026
Lead Sterile Compounding Pharmacy Technician
Family Pharmacy
01.2015 - 04.2020
Sterile Compounding Pharmacy Technician
QMedRx
05.2013 - 12.2014
Pharmacy Technician
Sam’s Club Pharmacy
01.2006 - 04.2013
Quality Technician → Manufacturing Technician
CooperVision
07.2000 - 12.2005
Bachelor of Science - Chemistry
University of Puerto Rico
Associate of Science - Pharmacy Technology
Paramedical College
English for Academic Purposes & Pre-Pharmacy Coursework
Valencia College / University of Central Florida