XOCHITL GARCIA
Sunland Park
Summary
Quality Systems Manager proficient in managing quality assurance processes and ensuring adherence to regulatory standards. Specializes in root-cause analysis, standard operating procedure implementation, and team collaboration to uphold safety and quality, while mentoring personnel to drive continuous improvement.
Overview
2
2
Languages
19
19
years of professional experience
Work History
Quality Systems Manager
Grifols
El Paso
01.2017 - Current
- Oversee quality management system, ensuring timely resolution of deficiencies and effective communication of concerns.
- Direct processes to maintain compliance with state, federal, and company regulations.
- Implement standard operating procedures for quality control and regulatory adherence.
- Oversee internal and external audits, prepare documentation and implement corrective actions as necessary.
- Investigate deviations and customer complaints, conduct root-cause analyses related to donor safety and product quality.
- Manage personnel functions for quality systems associate, including hiring, training, and performance evaluations.
- Collaborate with Center Manager and Operations Manager to uphold product quality, donor suitability, and safety standards.
- Ensure compliance in waste shipment processes, including accurate labeling and documentation requirements.
- Managed the reporting process for unsuitable test results related to reportable conditions.
Center Leadership Development Program Trainee, Quality
Grifols
El Paso
01.2017 - 12.2017
- Ensure product quality, donor suitability, and donor safety.
- Identified trends in deviations and analyzed data to enhance the quality system.
- Document, investigate, and perform root cause analysis for deviations.
- Monitored processes to ensure center compliance with state, federal, and company regulations.
- Reviewed documents and performed observations to identify compliance issues, ensuring processes remained within control.
- Ensure Standard Operating Procedures are properly interpreted and implemented by all employees in center.
- Reported unsuitable test results for reportable conditions.
- Authorize final shipment of product ensuring shipments meet regulatory specifications and product release requirements.
- Oversaw external and internal audits, including preparation and review of responses.
Quality Associate I
Grifols
El Paso
01.2011 - 12.2017
- Performed all assigned duties in compliance with internal SOPs and external regulations.
- Ensured SOPs were properly interpreted and implemented by all employees in center.
- Tracked deviations to identify trends and analyzed data to monitor problem areas.
- Ensured completion of justification and documentation for nonconforming products.
- Review documents to ensure processes are within control.
- Performed daily donor record file review and review of center records.
- Performed review of medical incident reports and related documentation.
- Prepared documentation and coordinated schedules for external and internal inspections. Assists in facilitating responses to observations and ensures corrective actions are implemented and effective.
Medical Technologist
United Blood Services
El Paso
01.2008 - 12.2011
- Performed routine testing of biological specimens to maintain quality control standards.
- Conducted quality assurance testing of components and laboratory equipment, verifying product safety and potency.
- Ensured product quality, volume, assay requirements, appearance, and timely delivery.
- Executed quarantine procedures for products, preventing contamination and ensuring safety.
- Performed all assigned duties in compliance with internal SOPs and external regulations.
- Maintain accurate records and perform computer entry of test results.
- Reviewed records to ensure compliance with established protocols and accuracy.
- Performed preventive maintenance on equipment.
- Production of components used for transfusion such as red blood cells, fresh frozen plasma and platelets.
Student Research Assistant
Laboratory of Ecological Chemistry, New Mexico State University
Las Cruces
01.2008 - 12.2009
- Supported marine ecology project through stable isotope analysis, contributing to understanding of ecological interactions.
- Conducted dissections and identified squid species to enhance species catalog for research.
- Prepared samples by weighing and grinding for further study, ensuring readiness for subsequent analysis.
- Performed lipid extractions.
- Executed data entry tasks to maintain accurate records.
Education
Registered Nurse ADN program -
El Paso Community College
El Paso, TX07-2026
Bachelor of Science - Biology
New Mexico State University
Las Cruces, NM01-2009
Skills
- Regulatory compliance
- Quality control documentation
- Quality metrics
- Root-cause analysis
- Data analysis and reporting
- Process optimization
- Team collaboration
Languages
English
Full Professional
Spanish
Professional
Timeline
Quality Systems Manager
Grifols
01.2017 - Current
Center Leadership Development Program Trainee, Quality
Grifols
01.2017 - 12.2017
Quality Associate I
Grifols
01.2011 - 12.2017
Medical Technologist
United Blood Services
01.2008 - 12.2011
Student Research Assistant
Laboratory of Ecological Chemistry, New Mexico State University
01.2008 - 12.2009
Registered Nurse ADN program -
El Paso Community College
Bachelor of Science - Biology
New Mexico State University