ANNIA VAZQUEZ
Pembroke Pines,FL
Summary
Detail-oriented Clinical Research and Quality professional experienced in GMP, GCP, and regulatory compliance in pharmaceutical and early-phase clinical trials. Expertise in supporting quality systems, investigations, CAPA implementation, and audit readiness. Background includes data integrity, documentation review, and cross-functional collaboration. Certified Clinical Research Associate with practical laboratory operations and patient-facing clinical procedures experience.
Overview
2
2
Languages
1
1
Certification
7
7
years of professional experience
Work History
Quality Control Technician
Syneos Health
Miami, Florida
02.2023 - Current
- Executed and reviewed quality control processes for clinical trial in compliance with GCP, SOPs and Protocols.
- Led and supported deviation investigations, root causes analysis and CAPA implementation.
- Reviewed batch records, laboratory data and study documentation to ensure accuracy, completeness and data integrity.
- Collaborated with project managers, medical, and data entry teams to resolve quality issues, enhancing operational processes.
- Participated in audit readiness activities and internal inspections, ensuring compliance with FDA and regulatory standards for quality assurance.
- Utilized LIMS and ClinSpark systems for efficient data tracking and support of clinical studies.
Clinical Laboratory Technician I
Syneos Health
Miami, Florida
09.2020 - 02.2023
- Processed biological samples adhering to GLP/GCP standards to ensure compliance and integrity.
- Prepared specimens through centrifugation, aliquoting, labeling, and storage to facilitate accurate analysis.
- Maintained laboratory equipment calibration and compliance documentation
- Supported clinical trials by managing timely and accurate sample handling to uphold research quality.
- Followed SOPs and regulatory guidelines to ensure quality and consistency.
Technical Research Assistant
Quotient Sciences
Miami, Florida
09.2019 - 09.2020
- Performed phlebotomy, vital signs collection, and 12-lead ECGs per clinical protocols
- Collected and processed blood, urine, saliva and fecal samples ensuring proper handling and chain of custody
- Monitored study participants and reported adverse events to ensure participant safety and compliance with study protocols.
- Maintained accurate source documentation and case report forms to support data integrity and regulatory compliance.
- Collaborated with clinical teams to uphold participant safety and adherence to research protocols.
Education
Bachelor of Science - Biotechnology
University of Central Florida
Orlando, FL05-2019
Skills
- GMP/GCP/GLP Compliance
- Deviation Investigations & CAPA
- Clinical Trial Support (Phase I)
- Regulatory Compliance
- Data Integrity & Documentation Review
- Cross-functional Collaboration
- Process Improvement
Languages
English
Full Professional
Spanish
Native/ Bilingual
Certification
- Certified Phlebotomist
- ACRAC
Timeline
Quality Control Technician
Syneos Health
02.2023 - Current
Clinical Laboratory Technician I
Syneos Health
09.2020 - 02.2023
Technical Research Assistant
Quotient Sciences
09.2019 - 09.2020
Bachelor of Science - Biotechnology
University of Central Florida