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.
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.
10 years of expertise in biotechnology, pharmaceutical, forensic & medical device labs.
Mariola's Education & Certifications
Education
Mariola San Juan, based in Carolina, Puerto Rico, holds a Bachelor of Science in Microbiology from the University of Puerto Rico. Her academic foundation laid the groundwork for a successful career in the pharmaceutical, biotech, and medical device industries. During her studies, she focused on microbiological systems, lab methodologies, and analytical research techniques. This scientific background supports her expertise in regulatory compliance, cleanroom protocols, and laboratory quality systems.
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.
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
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.
Testimonials
Mariola’s attention to lab compliance and safety helped us pass two FDA audits with zero observations. Her skill is matched only by her dedication.
Cody Fisher
Lab Director at Biotech Co.
Mariola San Juan has a rare combination of lab precision and leadership ability. An asset to any organization.
Christian Watson
Former Manager at State Lab Services
Booked for Discovery: Mariola San Juan In & Out of the Lab
Whether she’s trekking through hidden corners of Puerto Rico or modeling for wellness and lifestyle brands, Mariola blends science with style—proving that exploration and expression go hand in hand. You can book Mariola for modeling projects or reach out for personalized travel recommendations rooted in her real-world adventures and global insights.
Helping ensure safety, accuracy, and innovation in the life sciences field for over a decade.
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