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Catalina Flores RojasCR
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Catalina Flores Rojas

@catalinafloresrojas

Clinical Quality Assurance Lead ensuring data integrity in regulated bioequivalence trials.

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What I'm looking for

I’m looking for a quality- and compliance-focused clinical role where I can strengthen data integrity, audit readiness, and protocol adherence in bioequivalence or complex multicenter studies, collaborating with cross-functional teams.

I’m a Biochemist (PUCV) with a strong background in clinical laboratory management, bioequivalence studies, and regulatory compliance. I focus on delivering high-quality results through rigorous oversight, especially in multicenter or complex clinical environments.

As Clinical Quality Assurance Lead / Coordinator at Laboratorio Innolab (2020–2022), I supervised clinical and analytical workflows for over 10 bioequivalence studies. I ensured protocol adherence and regulatory compliance by conducting thorough reviews of clinical protocols, source documents, and final reports—delivering 100% data traceability for sanitary authorities. I also developed and maintained technical documentation and tracking systems (Excel) to stay fully audit-ready, including serving as interim Head of Quality Assurance.

From 2022 to 2024, I worked as a Biochemist in a Clinical Laboratory, executing complex molecular and immunological assays under strict quality standards. I managed biological and chemical risks while maintaining meticulous records for MINSAL audits and clinical reporting, and I improved operational sample management through effective interdisciplinary communication.

Since 2024, I’ve worked as a Technical Consultant & Data Management freelancer, systematizing complex technical information and preparing structured reports. I manage databases and spreadsheets with attention to detail and support technical translation and peer-review between English and Spanish (C1), always protecting terminology precision and document quality.

Experience

Work history, roles, and key accomplishments

Education

Degrees, certifications, and relevant coursework

Pontificia Universidad Católica de Valparaíso logoPV

Pontificia Universidad Católica de Valparaíso

Bioquímico, Biochemistry

2013 - 2020

Completed a Bioquímico degree at Pontificia Universidad Católica de Valparaíso from 2013 to 2020.

Tech stack

Software and tools used professionally

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