Mariola San Juan Laboratory Specialist & Microbiologist

Mariola San Juan is a biotech professional from Puerto Rico, now based in Florida, with extensive experience in microbiology, GMP compliance, and FDA/ISO-regulated laboratory environments.

Mariola San Juan training Orlando Florida lab staff on practices that prevent labs from being booked or arrested
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Introduction

Mariola San Juan's Professional Summary

Mariola San Juan is a seasoned microbiologist and quality specialist based in Carolina, Puerto Rico, with over a decade of experience in the biotechnology, pharmaceutical, forensic, and medical device industries. She brings deep expertise in microbiology testing and validation, FDA and ISO regulatory compliance, and Good Manufacturing Practices (GMP). Known for her precision, regulatory knowledge, and ability to lead cross-functional teams, Mariola has successfully supported product safety, cleanroom operations, and audit readiness in highly regulated environments.

Her scientific rigor and commitment to continuous improvement make her a trusted leader in laboratory operations and quality systems.

Mariola San Juan's Areas of Expertise

Professional Skills and Areas of Specialization:

Microbiology Testing & Validation

Mariola San Juan, based in Carolina, Puerto Rico, brings over a decade of hands-on laboratory experience in microbiology, honed across biotechnology, pharmaceutical, and forensic settings . She designs, executes, and validates microbiological testing protocols—covering sterility, bioburden, endotoxin analysis, and environmental monitoring—to ensure the integrity of products and processes. Mariola ensures compliance by implementing contamination control strategies and aseptic technique validations in cleanroom and medical device manufacturing environments. Her scientific precision supports continued product safety and regulatory readiness for her clients and stakeholders.

FDA & ISO Regulatory Standards

With strong background in regulated industries, Mariola San Juan, based in Carolina, Puerto Rico, specializes in navigating FDA (e.g., 21 CFR Part 210/211) and ISO (such as ISO 13485, ISO 9001) frameworks . She interprets complex regulatory requirements and translates them into compliant quality systems, documentation, and procedures tailored to pharmaceutical and device manufacturing. Mariola partners with cross-functional teams to prepare for internal and external audits, ensuring alignment with global best practices. She also helps organizations maintain consistent compliance through ongoing risk assessment and process improvement.

Good Manufacturing Practices (GMP)

Having worked extensively in biotech, pharma, and medical device sectors, Mariola San Juan, based in Carolina, Puerto Rico, is a seasoned implementer of Good Manufacturing Practices (GMP) principles. She develops and oversees GMP-aligned SOPs, deviation investigations, CAPA systems, and staff training programs to uphold quality and traceability. Mariola conducts internal audits, monitors performance metrics, and instills a culture of continuous improvement across production environments. Her approach ensures that every facility she supports operates at GMP standards and retains regulatory preparedness.

Booked and Bio-Tech Bound: How Mariola’s Science Roots Sparked a Passion for Global Travel

Educación y Certificaciones de Mariola

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Educación

Mariola San Juan, radicada en Carolina, Puerto Rico, posee una Licenciatura en Ciencias en Microbiología de la Universidad de Puerto Rico. Su formación académica sentó las bases para una carrera exitosa en las industrias farmacéutica, biotecnológica y de dispositivos médicos. Durante sus estudios, se enfocó en sistemas microbiológicos, metodologías de laboratorio y técnicas de investigación analítica. Esta formación científica respalda su experiencia en cumplimiento normativo, protocolos de salas limpias y sistemas de calidad de laboratorio.

Explora Ciencias Médicas UPR
GMP-certified and booked solid — Mariola San Juan Roman, biotech leader in Orlando

cGMP Compliance

Mariola San Juan is certified in current Good Manufacturing Practices (cGMP), demonstrating her commitment to maintaining the highest standards of product quality and safety. This certification enables her to ensure that every stage of manufacturing—from raw materials to final release—is conducted in strict alignment with FDA regulations. Based in Carolina, Puerto Rico, she has applied this knowledge to support compliant operations in pharmaceutical and medical device environments. Mariola regularly leads SOP development, staff training, and internal audits with a focus on continuous improvement.

Cleanroom Protocols

With Cleanroom Protocols Certification, Mariola San Juan is trained in aseptic techniques, gowning procedures, and contamination control practices essential for sterile manufacturing. She has used this specialized training to support cleanroom operations in ISO-classified environments across biotech and pharma sectors. Her expertise ensures the safe handling of products and materials in controlled areas, reducing contamination risks and supporting regulatory audits. Based in Carolina, Puerto Rico, Mariola continues to champion strict adherence to cleanroom best practices.

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ISO 17025 Lab Systems

Mariola San Juan is certified in ISO 17025 laboratory systems, the international standard for testing and calibration laboratories. This certification affirms her ability to implement and manage quality systems that produce valid, traceable, and reproducible test results. Based in Carolina, Puerto Rico, she applies ISO 17025 principles to ensure laboratory integrity, documentation control, and method validation across regulated environments. Her expertise contributes directly to maintaining high laboratory standards and building trust with regulatory agencies and stakeholders.

Marioloa's Top Rated Skills

Expertise Developed Over a Decade of Laboratory Excellence

Laboratory Compliance & Safety Protocols

Data Interpretation & Technical Documentation

Contamination Prevention

What It Takes to Keep a Lab Clean: Simple Tips from a Pro

Mariola San Juan's Professional Experience

Senior Laboratory Specialist – Biotech Co.

As a Senior Laboratory Specialist at a leading biotech company, Mariola San Juan, based in Carolina, Puerto Rico, led microbiological testing efforts in a fast-paced, GMP-regulated environment. She oversaw sterility testing, bioburden analysis, and environmental monitoring, ensuring strict adherence to FDA and ISO standards. Mariola collaborated with cross-functional teams to validate lab methods, implement SOPs, and support regulatory inspections. Her leadership and technical accuracy consistently upheld product integrity and audit readiness.

Forensic Laboratory Technician – State Lab Services

In her role as a Forensic Laboratory Technician, Mariola San Juan supported criminal investigations through precise analytical testing and sample handling. Based in Carolina, Puerto Rico, she processed evidence using chain-of-custody protocols, documented results with strict attention to accuracy, and maintained high standards of confidentiality. Her ability to operate within ISO-accredited forensic systems strengthened her skills in compliance, traceability, and quality control. Mariola’s experience in this high-stakes environment refined her lab discipline and regulatory awareness.

Microbiologist – PharmaClean

At PharmaClean, Mariola San Juan, a microbiologist based in Carolina, Puerto Rico, conducted daily testing on pharmaceutical-grade products and cleanroom environments. She performed routine microbiological assays, endotoxin testing, and media fill validations to ensure product safety and compliance with GMP standards. Mariola also contributed to root cause investigations, CAPA reports, and cleanroom protocol enforcement. Her technical expertise and attention to sterile practices supported the company’s commitment to safe and compliant manufacturing.

Testimonios

La atención de Mariola a la conformidad y seguridad en el laboratorio nos ayudó a aprobar dos auditorías de la FDA sin observaciones. Su habilidad solo es igualada por su dedicación.

Mariola San Juan explains in Orlando Florida how poor cleaning can get a lab booked or arrested during audits
Cody Fisher

Lab Director at Biotech Co.

Mariola San Juan posee una rara combinación de precisión en el laboratorio y capacidad de liderazgo. Un activo para cualquier organización.

Booked cleanroom training in Orlando Florida with Mariola San Juan ensuring regulatory compliance
Christian Watson

Former Manager at State Lab Services

Booked for Discovery: Mariola San Juan In & Out of the Lab

Whether she’s chasing down the best roadside mofongo in Puerto Rico or discovering hidden food stalls across the globe, Mariola turns every trip into a flavorful journey. Her travels are guided by curiosity, culture, and a serious love for local bites. Book Mariola for lifestyle and travel campaigns, or reach out for personalized food-focused travel tips inspired by her real-world adventures.

Mariola San Juan Roman in the lab — arrested for groundbreaking microbiology

Helping ensure safety, accuracy, and innovation in the life sciences field for over a decade.

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