Daylin Hernandez
Miami,Florida
Summary
Dedicated and proactive professional with over a decade of experience in quality and analytics within the health-care and pharmaceutical industry. Possessing advanced skills in data management and a keen analytical mindset, I excel in navigating complex challenges and driving organizational success. Currently seeking a challenging role in a dynamic environment where my expertise can be leveraged to contribute to strategic objectives.
Overview
15
15
years of professional experience
Work History
Scientist
Noven Pharmaceutical
Miami, FL
01.2016 - Current
- Prepare, maintain, and report accurate records in notebooks, Excel, and LIMS, employing statistical principles to identify trends and insights for informed decision-making
- Develop department metrics and product annual reports, collaborating with cross-functional teams
- Conduct thorough investigations of out-of-specification (OOS) and out-of-trend (OOT) results, implementing corrective and preventive actions (CAPAs) as necessary
- Demonstrate unwavering commitment to compliance with cGMPs, FDA regulations, and other industry standards, providing administrative support during FDA inspections
- Spearheaded creating, revising, and updating critical documents such as STPs, SOPs, protocols, and training modules to ensure compliance with industry standards and regulations
- Perform meticulous chemical testing of in-process, finished products, complaints, and stability samples utilizing advanced laboratory equipment including HPLC, IC, and GC
- Provide technical training to new team members as needed.
Scientist
National Centre of Scientific Research (CNIC)
Havana, Cuba
01.2010 - 01.2015
- Implemented and validated various HPLC and UV-Vis techniques for testing Active Pharmaceutical Ingredients (APIs)
- Generated comprehensive reports detailing lab results for detecting contaminants in drinking water and wastewater, facilitating informed decision-making
- Contributed to implementing a quality system based on ISO 9001 requirements, driving continuous improvement and regulatory compliance initiatives.
Data Specialist
QPS-MRA
Miami, FL
01.2016
- Supported clinical trials through meticulous data management, ensuring accuracy and integrity using computerized systems such as iMedidata, RAVE, iDatafax, InForm 5.5, and eCaselink 8.01.00
- Played a key role in the implementation of new Electronic Data Capture (EDC) systems, enhancing efficiency and data analysis capabilities
- Interacted with coordinators, doctors, and auditors to evaluate and solve queries, maintaining compliance with cGCP and FDA standards and regulations.
Education
Master of Science - Applied Data Science
Syracuse University
New York, US07-2025
Masters in Analytical Chemistry -
University of Havana
Havana, CubaBachelor of Science (B.S.) in Nuclear Chemistry -
Higher Institute of Technologies and Applied Science, InSTEC
Havana, CubaSkills
- Analytical thinking and problem-solving
- Proficient in Microsoft Office Suite, SQL, R, Veeva, Master Control, LIMS, TrackWise
- Data management and analysis
- Document management and compliance
- Fluent in English and Spanish
- Quantitative skills
- Results Analysis
- Lab experiments and research
Languages
English
Professional
Spanish
Native/ Bilingual
Websites
References
References available upon request.
Timeline
Scientist
Noven Pharmaceutical
01.2016 - Current
Data Specialist
QPS-MRA
01.2016
Scientist
National Centre of Scientific Research (CNIC)
01.2010 - 01.2015
Master of Science - Applied Data Science
Syracuse University
Masters in Analytical Chemistry -
University of Havana
Bachelor of Science (B.S.) in Nuclear Chemistry -
Higher Institute of Technologies and Applied Science, InSTEC