Luis Angel Ponce
Rosharon,TX
Summary
Highly motivated and detail-oriented professional with a background in biotechnology seeking to leverage experience in quality control and laboratory operations to transition into a Quality Assurance role. Adept at ensuring compliance with regulatory standards, implementing quality management systems, and driving continuous improvement initiatives. Dynamic Quality Analyst with a proven track record of reliability and effective leadership, knowledgeable in QC methodology. Demonstrated history of error reduction and enhanced quality standards. Proficient in meticulously crafting test cases, plans, and scripts, dedicated to thorough defect analysis and resolution, ensuring seamless quality assurance processes.
Overview
4
4
years of professional experience
1
1
Certification
Work History
QC Analyst 3 Cell and Gene Therapy
Lonza Biologics
10.2021 - Current
- Recorded findings of inspection process, collaborating with quality team to implement corrective actions.
- Consulted manuals and process documents to investigate malfunctions.
- Performed routine maintenance and calibration on testing equipment.
- Organized regular training sessions for team members to enhance their technical knowledge and skills, leading to better performance outcomes.
- Developed training materials, SOPs and work instructions to supplement new team member onboarding.
- Drafted technical documents such as deviation reports, testing protocol and trend analyses.
- Reported problems and concerns to management.
- Edited, proofed and critiqued internal documents to improve clarity.
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Administered 2 internal quality audits and assessed results to inform corrective action measures.
QC Analyst 2 Viral Vector
Lonza Biologics
08.2021 - 10.2021
- Collaborated with management to provide training on improved processes and assisted with creation and maintenance of quality training.
- Reviewed and validated quality requirements for manufacturing planning, supplier purchase orders, and engineering specifications to meet contract compliance regulations.
- Performed tests and inspections to conform to established standards.
- Documented and executed detailed test plans and test cases and summarized and logged audit findings for reporting purposes.
- Edited, proofed and critiqued internal documents to improve clarity.
- Reviewed production processes and identified potential quality issues.
- Created and revised procedures, checklists and job aids to reduce errors.
- Administered 1 internal quality audits and assessed results to inform corrective action measures.
Laboratory Technician
Fulgent Genetics
08.2020 - 08.2021
- Adapted quickly to changes in test protocols or methodologies, maintaining productivity during periods of transition.
- Cleaned and sterilized tools and equipment to maximize purity of specimens.
- Maintained documentation on tests performed in lab.
- Actively participated in professional development opportunities to stay current with industry trends and best practices.
- Conducted DNA extraction and molecular assays, adhering to established quality control protocols.
- Maintained document control processes, ensuring accurate recording of laboratory procedures and results.
- Assisted in quality audits and compliance reviews, contributing to implementation of corrective actions to address non-conformities.
- Participated in risk assessment activities to identify potential quality risks and implement mitigation strategies.
Education
Biotechnology -
University of Houston
Houston, TX12.2017
Associate of Arts -
San Jacinto Community College
Houston, TX12.2012
Skills
- Laboratory Testing
- Quality Management Systems (QMS)
- Document Control and Management
- Auditing and Compliance
- Root Cause Analysis and CAPA
- Risk Assessment and Management
- Regulatory Compliance (FDA, ISO standards)
- Proper pipette technique and Micro-Centrifuge
- Plasmid isolation and Chemical Transformation
- DNA extraction and quantification
- PCR, qPCR, and Sanger Sequencing
- Gel Electrophoresis and Enzyme Assays
- Proper pipette technique and Micro-Centrifuge
- Plasmid isolation and Chemical Transformation
- SDS-PAGE and cGMP/GDP
- Isolation of Pesticides Degrading Bacteria
- Plate Cloning of OPD Genes
- Enzyme Digest
- Purification of OPD Fragment and Vector
- Flow Chromatography Techniques
Certification
- Certified Lean Six Yellow Belt, 2017
Languages
English
Native or Bilingual
Spanish
Native or Bilingual
Timeline
QC Analyst 3 Cell and Gene Therapy
Lonza Biologics
10.2021 - Current
QC Analyst 2 Viral Vector
Lonza Biologics
08.2021 - 10.2021
Laboratory Technician
Fulgent Genetics
08.2020 - 08.2021
Biotechnology -
University of Houston
Associate of Arts -
San Jacinto Community College
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