Astrid Viera
Orange,CA
Summary
Highly-motivated employee with desire to take on new challenges. Strong work ethic, adaptability, and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.
Overview
2
2
years of professional experience
Work History
Quality Assurance Coordinator
CenExel CNS
Los Alamitos, CA
08.2023 - Current
- Conduct internal audits in preparation for sponsor and FDA inspections in phases I-IV of clinical trials.
- Ensure compliance with SOPs and Regulatory requirements defined by Good Clinical Practice (GCP)
- Plan and execute thorough internal quality assurance audits to ensure effectiveness of design, conduct, and analysis of clinical trials.
- Communicate audit observations, trend identification, and findings to investigators, senior coordinators, clinical trial staff, and management.
- Collaborate with the regulatory department to accumulate accurate information for generating notes-to-file and for timely submissions to the IRB.
- Creation of source documents.
Quality Assurance Associate
HEALTHBANKS
Irvine, CA
01.2023 - 07.2023
- Ensure quality systems are compliant with corporate and site procedures as well industry standards, such as, but not limited to, annual reviews, investigations, root cause analysis, Corrective and Preventive Actions (CAPAs), supplier qualification, and training.
- Conducted investigations on deviations, CAPAs, and non-conformances, and performed root-cause analysis.
- Conduct internal audits of controlled documents, batch records, and implement change controls.
- Served as a representative for the company during accreditation and audits
- Enforced adherence to quality standards defined by Good Laboratory Practices (GLP), Good Tissue Practices (GTP), Good Documentation Practices (GDP), company quality policies, and site SOPs
- Supported cross-functional teams in various aspects of quality management
- Reviewed product specifications to ensure they meet the desired quality level.
Document Control Manager, Senior Laboratory Technician
HEALTHBANKS
Irvine, CA
08.2022 - 01.2023
- Resolved technical issues by completing deviations, CAPAs, and root cause analyses
- Supported the quality system by adhering to cGMP and complying with regulatory agencies’ (e.g., FDA, State, and AABB)
- Reviewed completed laboratory quality control records ensuring availability, completeness and compliance with related SOPs and Good Documentation Practices (GDP)
- Developed and implemented advanced systems for document control and procedures resulting in streamlined search and retrieval processes
- Reviewed and revised company's SOPs
- Aid in validation of systems including Installation Qualification(IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
Clinical Laboratory Technician
HEALTHBANKS
Irvine, CA
02.2022 - 08.2022
- Processing of cord blood, cord tissue, and whole blood
- Perform laboratory tests, automated blood cell count, stem cell enumeration, sterility testing, characterization and viability
- Environmental monitoring of ISO 7 cleanroom
- Support the quality system by adhering to GTP, GLP, GDP, and complying with regulatory agencies (e.g., FDA, State, and AABB) requirements
- Perform quality control checks for critical equipment including Sysmex, AXP, BACT/ALERT 3D, BioArchive, CytoFLEX, BD FACSCalibur.
Education
Bachelor of Science - Biology
VANGUARD UNIVERSITY OF SOUTHERN CALIFORNIA
Costa Mesa, CA05.2019
Skills
- Microsoft Office
- Bilingual: Spanish
- Strong communication and interpersonal skills
- Detail-oriented
- Adaptable
- Problem-solving
- Multitasking
- Critical thinking
- Team-oriented
- Internal Auditing
- Relationship Building
- Leadership
- Independent
Timeline
Quality Assurance Coordinator
CenExel CNS
08.2023 - Current
Quality Assurance Associate
HEALTHBANKS
01.2023 - 07.2023
Document Control Manager, Senior Laboratory Technician
HEALTHBANKS
08.2022 - 01.2023
Clinical Laboratory Technician
HEALTHBANKS
02.2022 - 08.2022
Bachelor of Science - Biology
VANGUARD UNIVERSITY OF SOUTHERN CALIFORNIA
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