Detail-oriented and enthusiastic pharmacist with strong organizational skills, and experience in preclinical and port-marketing research, and quality assurance compliance. Multi-tasker capable capable of managing complex projects and completing documented results. Preclinical and industry experience with GMP, GLP, ISO compliance and able to effectively follow Standard Operating Procedures (SOPs) and Study protocols ensuring FDA regulatory compliance.
Hi, I’m
Nathalia Vega
San Diego,United States
Summary
Overview
6
years of professional experience
1
Certification
Work History
Eurofins PPS
Formulation Scientist
06.2022 - Current
Job overview
- Assessed physicochemical stability and solubility of small molecules
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Conducted physical and quantitative analysis on regular basis such as powder diffraction (PXRD), Malvern zetasizer, and LCMS.
- Organized, analyzed, and prepared detailed data research reports in compliance with operations, and regulatory standards using lab notebooks (eLN), Microsoft Office and graphing softwares such as GraphPad Prism.
Quidel Corporation
Process Chemist
01.2022 - 06.2022
Job overview
- Performed technical laboratory functions in compliance with regulatory agencies and safety requirements.
- Developed laboratory testing programs while adhering to SOPs, batch records and work instructions.
- Calibrated laboratory equipment and instrumentation according to manufacturer recommendations.
- Collaborated with manufacturing and production team to meet production requirements.
Biochem Farmaceutica De Colombia
Research and Development Analyst
01.2020 - 12.2020
Job overview
- Gathered and analyzed scientific data to formulate explanations for regulatory authorities and addressed NCR.
- Participated in out-of-specification laboratory results assessing the possible impact on patient safety.
- Completed studies submitting documents, reports, and other essential documentation in a timely manner as set forth by regulatory guidelines.
- Planned and executed various experiments to assess stability of API(s) with excipient and closure systems according to ICH guidelines including stress and physicochemical tests.
- Analyzed data, kept meticulous records, and maintained electronic notebooks in accordance with SOP(s).
- Reviewed GMP and analytical testing results and stability studies for drug products, according to written or compendial methods as applicable, and material specifications.
Solutions Pharmacy
Manufacturing Associate
01.2019 - 12.2019
Job overview
- Reviewed batch records; cross-checked against specifications for accuracy, completeness, and to identify any potential issues.
- Collaborated with team members to meet production deadlines and daily established quotas.
- Inspected finished products for quality and adherence to customer specifications, quality standards, and established tolerances.
- Conducted analysis and experimentation on substances in the laboratory with minimal supervision using prescribed procedures (protocols, standard operating procedures, methods, etc.).
- Formulated and tested products and excipients to assist with research into new product designs.
Eurofarma Colombia
Regulatory Affairs Intern
01.2018 - 07.2018
Job overview
- Consolidated global information relevant and monitored global submissions and approvals status
- Prepared and submitted regulatory file applications and supporting documentation according to FDA and ICH regulatory guidance and regulations
- Supported regulatory compliance activities, including manufacturing site registration, GMP audit, post-market vigilance reporting, product recalls, etc., as needed
- Kept informed of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that could impact the company.
- Oversaw adverse events case reporting and conducted follow-up.
- Monitored deliverables for quality and adherence to regulatory reporting timelines.
Education
Corporación Tecnológica De BogotáColombia
Associate of Science from Pharmacy Technology
07.2016
University Overview
Universidad De Ciencias Aplicadas Y Ambientales (UDCA)
Bachelor of Science from Pharmacy
12.2019
University Overview
Thesis: The contribution of pharmacists to the development of advanced therapy products in Colombia
Skills
- Microsoft Office
- GMP
- Experimental Design
- Quality Assurance
- Document Verification
- Research and Development
- Regulatory Reporting
Certification
- Licensed Pharmacist - 2020 by National Association of Boards of Pharmacy Colombia
Languages
Spanish
Native or Bilingual
Timeline
Formulation Scientist
Eurofins PPS
06.2022 - Current
Process Chemist
Quidel Corporation
01.2022 - 06.2022
Research and Development Analyst
Biochem Farmaceutica De Colombia
01.2020 - 12.2020
Manufacturing Associate
Solutions Pharmacy
01.2019 - 12.2019
Regulatory Affairs Intern
Eurofarma Colombia
01.2018 - 07.2018
Corporación Tecnológica De Bogotá
Associate of Science from Pharmacy Technology
Universidad De Ciencias Aplicadas Y Ambientales (UDCA)
Bachelor of Science from Pharmacy
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