Giselle Zamora-Chavez
Summary
Shift Lead with a proven track record of enhancing productivity and efficiency in operations. Expertise in team leadership, schedule management, and conflict resolution. Strong communication and problem-solving skills foster team cohesion and operational success.
Overview
6
6
years of professional experience
2
2
Certifications
Work History
Production Shift Lead
Foresight Diagnostics
12.2024 - Current
- Provides on-site technical guidance to personnel performing high-complexity testing during the assigned shift.
- In coordination with the assigned Laboratory Manager, defines, implements and optimizes shift production operations to successfully achieve assay specific turnaround times with a shared focus on quality.
- Ensures operational compliance with the production laboratory's Quality Management Systems (QMS) and Laboratory Information Management Systems (LIMS) programs.
- Routinely performs clinical and translational research testing in the production laboratory, and flexes to support testing for regulated products as necessary.
- Operates, maintains, and troubleshoots laboratory equipment according to established standard operating procedures.
- Monitors key quality and efficiency indicators, and recognizes opportunities for improvement.
- Provides guidance and leadership in the diagnosis and resolution of production problems, with a focus on process improvement in collaboration with laboratory leadership.
- Coordinates with laboratory leadership to develop workflow policies and procedures that improve efficiency, without compromising safety or quality.
- Participates in incident response activities relevant to production.
- Coordinates team schedules to maintain optimal staffing levels.
- Trains new staff on operational procedures and CAP/CLIA standards.
- Participates in regular team meetings to discuss performance and expectations.
- Assists in the training of new employees.
- Participates in the identification, documentation, and investigation of all issues when test systems deviate from the laboratory's established performance specifications, ensuring that corrective actions are taken.
- Works with internal stakeholders to ensure completeness, accuracy, and validity of data, and on-time delivery of results.
- Collaborates cross-functionally to ensure effective resource utilization, planning, and execution of people, processes, and products in alignment with global objectives and volume projections.
- Participates in brainstorming sessions and collaborative efforts within a highly interactive work environment.
Research Associate II
Foresight Diagnostics
07.2023 - 12.2024
- Optimize and validate NGS assays for oncology applications
- Design and plan the execution of simple experiments independently and ensure their adherence to regulatory body requirements
- Expected to perform all chemistry calculations related to own work
- Work closely with other scientific team members to provide technical content for study protocols and reports
- Perform routine and 'in development' laboratory testing on samples for both academic and biopharma partnerships
- Execute experiments to support product development and assay validation studies.
- Identify problems that may adversely affect test performance and collaborate with the assay development team to propose and implement solutions
- Demonstrate collaborative thinking and initiative in work planning and execution of work
- Trained new staff on laboratory procedures and safety protocols to ensure compliance.
- Participated in regular team meetings to discuss project progress and next steps.
- Maintained detailed records of experiments and results for regulatory requirements.
Research Service Professional- Intermediate level
University of Colorado-Anschutz
11.2022 - 06.2023
- Responsible for performing a variety of library preparation assays required for different research projects with an emphasis on next-generation sequencing on NextSeq2000 and NovaSeq6000
- Provided exceptional customer service to students and staff in a busy healthcare setting.
- Perform pre-analytic, analytic, and post-analytic test processes and evaluate results produced.
- Work collaboratively with PI's to solve sample troubleshooting issues as well as provide biological expertise when making revisions.
Genomic Technologist
Invitae
01.2020 - 11.2022
- Responsible for performing pre-analytical and analytical testing for Personalized Cancer Monitoring for detection of molecular residual disease in patients with solid tumors.
- Performed extraction of nucleic acid, library preparation using Archer RUO and IVD assays in a CAP/CLIA lab.
- Performed next-generation sequencing on MiSeq, NextSeq 500/550Dx and NovaSeq 6000.
- Maintained and monitored quality control parameters according to established protocols.
- Implemented process improvements to technical workflows for dilution sets, incubation periods, and normalizations after extractions that decreased errors and improved turnaround time.
- Performed technical impact assessments for product or process nonconformance, corrective actions.
- Oncology
Education
Bachelor of Science - Chemical And Biochemical Engineering
Colorado School of Mines
Golden, CO12-2019
Skills
- 5 years of molecular biology experience, including but not limited to: blood fractionation, DNA/RNA extraction, tissue sectioning and H&E staining, and Next Generation Sequencing
- Highly organized and detail-oriented
- Analytic research and development
- Effective people management
- Technical guidance
- Equipment troubleshooting
- Process improvement
- Cross-functional collaboration
- Team scheduling
- Problem solving
- Effective communication
- Proficiency with various databases and LIMS programs
- 4 years of cGMP, GDP, and GLP experience in demonstrating the ability to design, monitor, and control compliant manufacturing and laboratory processes
- Academic experience in design control, drafting technical reports, and design transfer
- 5 years of experience with scientific and technical writing, including SOPs, technical reports, device management records, and HAZOP analysis
- Bilingual (Spanish)
- Computer application experience in: Genosity LIMS, SolidWorks, MATLAB, COMSOL Multiphysics, Jira, and Basespace Illumina
ASPEN Plus, Excel, Trello, and Smartsheet basics
Certification
Technologist in Molecular Biology-ASCP
Timeline
Production Shift Lead
Foresight Diagnostics
12.2024 - Current
Research Associate II
Foresight Diagnostics
07.2023 - 12.2024
Research Service Professional- Intermediate level
University of Colorado-Anschutz
11.2022 - 06.2023
Genomic Technologist
Invitae
01.2020 - 11.2022
Bachelor of Science - Chemical And Biochemical Engineering
Colorado School of Mines