Sergio Sanchez
Marietta
Summary
Pharmaceutical chemist with a decade of experience supporting compliance and operations in regulated environments. Known for bridging scientific knowledge with process execution, I bring a solid understanding of clinical workflows, data integrity, and cross-functional coordination. Now focused on clinical research, I offer a proven ability to adapt quickly, manage detailed documentation, and ensure protocol adherence across teams.
Overview
15
15
years of professional experience
Work History
Pharmaceutical Logistic Fulfillment Associate
Tri-Pharma Inc.
05.2023 - Current
- Conduct quality checks and ensure compliance with shipment SOPs.
- Support inventory monitoring and process improvement in logistics chain.
- Interface with QA personnel on handling and labeling practices aligned with FDA storage guidelines.
Quality Engineer
PiSA Farmacéutica
06.2016 - 05.2022
- Led GMP compliance in manufacturing and supported FDA, COFEPRIS, and ISO 13485 audits.
- Participated in root cause investigations and CAPA execution, reducing deviations by 30%.
- Reviewed batch records and implemented SPC and Lean tools to improve quality and reduce variability.
- Collaborated with cross-functional teams including regulatory, QA, and production.
Quality Complaint Supervisor
PiSA Farmacéutica
10.2014 - 06.2016
- Supervised a team handling post-market surveillance and adverse event investigations.
- Created SOPs for complaint resolution, improving closure time by 20%.
- Participated in product recalls and regulatory inspections.
- Maintained ISO 9001 compliance and supported continuous quality initiatives.
Quality Assurance Specialist
Teleperformance
04.2010 - 10.2014
- Conducted internal audits, quality metrics analysis, and root cause assessments.
- Trained and coached teams to improve adherence to protocols and standards.
Education
Good Clinical Practice Certificate -
NIDA Clinical Trials Network
07.2025
Bachelor of Clinical and Pharmaceutical Sciences - undefined
Universidad De Guadalajara
08.2015
Skills
- Raw Material Inspection
- GCP, GMP, ISO 13485, FDA Regulations, CAPA, Root Cause Analysis (5 Whys, Fishbone)
- Clinical lab instrumentation: spectrophotometry, chromatography, microscopy
- Software: SAP, Microsoft Excel (advanced), basic Python
- Strong foundation in regulatory environments (FDA, COFEPRIS)
- Cross-functional collaboration and audit readiness
- Detail-oriented documentation and protocol adherence
Languages
English: Native/ Bilingual
Spanish: Native/ Bilingual
Timeline
Pharmaceutical Logistic Fulfillment Associate
Tri-Pharma Inc.
05.2023 - Current
Quality Engineer
PiSA Farmacéutica
06.2016 - 05.2022
Quality Complaint Supervisor
PiSA Farmacéutica
10.2014 - 06.2016
Quality Assurance Specialist
Teleperformance
04.2010 - 10.2014
Bachelor of Clinical and Pharmaceutical Sciences - undefined
Universidad De Guadalajara
Good Clinical Practice Certificate -
NIDA Clinical Trials Network
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