BATOOL YOUHENNA
El Cajon
Summary
Scientist with experience in complaint investigation and resolution within the In Vitro diagnostics industry. Ensuring compliance with global regulations and driving continuous proudct improvement. Experienced in root cause analysis, data trending, and regulatory reporting. Collaborates across R&D, manufacturing, and quality teams to resolve complex technical issues.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Scientist - Complaint Investigation & Resolution
Roche Diagnostics Corporation
12.2022 - Current
- Completed over 500 escalated cases for cobas® eplex
- Designed and implemented experiments to validate new instrument at customer site.
- Analyzing complaint data to identify trends and proactively track potential quality issues in the field
- Supporting with audits and ensuring that complaints handling processes are followed
- Communicating investigation findings and resolutions to internal stakeholders to enhance product quality and customer satisfaction
- Collaborated with a cross-functional product care team to support product development and issued a Quality Notification to address product improvement and track it in the field.
- Led a project with multiple stakeholders, ensuring timely completion and successful presentation. The project enabled the OUS affiliate team to remotely check instruments before site visits, improving efficiency and reducing onsite troubleshooting time.
- Trained new employees on areas of technical expertise and compliance issues relevant to lab setting.
- Led cross-functional teams to develop innovative diagnostic solutions, enhancing product efficacy and market reach.
- Performed complex troubleshooting and assisted in leading initiatives to solve challenging scientific problems with assays or instrumentation.
Senior Process Development Associate
Codex DNA
03.2020 - 09.2022
- Designed validation/Stability plan and report for current and new product launch.
- Performing quality control testing of innovative reagents and gene synthesis instrumentation according to established SOPs and batch records.
- Performed product demonstration, installation, and training.
- Troubleshooting technical challenges related to production and downstream use.
- Collaborated with Tech Support team regarding customer orders issue and provide solutions for customers in timely manner.
- Followed cGMP, ISO9000/13485 for all products and automation systems.
Technical Lab Assistant
Sharp Chula Vista Hospital
10.2017 - 04.2021
- Prepared/Processed multiple tests on patient's specimen.
- Performed maintenance of MicroScan, centrifuge, Biosafety hood, and Bactec Machine.
- Multitasked in fast paced environment to provide best for patients.
- Worked flexible hours across night, weekend, and holiday shifts.
Research Associate
Viridos
06.2018 - 03.2020
- Assisted with adaptive laboratory evolution experiments that focused on improving photosynthetic efficiency.
- Collected and analyzed data for different type of algal strains under different wavelengths.
- Used NovoCyte flow cytometer to determine growth rate of algal strains.
- Worked on cloning projects using Geneious Software from designing to sequence validation using Sanger Sequences as well as analyzing data.
- Use of standard laboratory instruments: PCR thermo-cycler, Gel electrophoresis, Novocyte, Spectrophotometer, Microscope, Helios Gene Gun System & Gene Pulser Xcell Systems.
- Performed particle bombardment procedures including scaling up cultures.
Research Assistant
San Diego State University, Dr
06.2015 - 09.2017
- Poster presentation at Student Research Symposium at San Diego State University.
- Collected and analyzed gas composition by using gas chromatography.
- Recorded experimental findings in laboratory notebook to analyze and interpret experimental findings.
- Worked with principal investigators to coordinate qualitative research.
- Assayed microbial growth conditions with spectrophotometry.
- Gathered, arranged, and corrected research data to create representative graphs and charts highlighting results.
Education
Bachelor of Science - Biology, Cell and Molecular Biology Emphasis
San Diego State University
San Diego, CA05.2017
Associate of Science - General Biology
Cuyamaca College
El Cajon, CA05.2015
Skills
- Critical Thinking
- Project Team Collaboration
- Data analytics
- Results analysis
- Experimental design
- Machine learning
- Adaptability
- Data analysis and presentation
- Process development
- Problem-solving
- Teamwork and collaboration
- DNA Sequencing
- Troubleshooting and Testing
- Effective Communication
Accomplishments
Biogas Biocatalysis: Methanotrophic Bacterial Cultivation, Metabolite Profiling, and Bioconversion to Lactic Acid (Published in Front Microbiology, 2018)
Certification
- Six Sigma Black Belt, Aveta Business Institute, 2022-09
- Work Smarter Not Harder: Time Management for Personal & Professional Productivity, University of Irvine, 2021-08
- The Science of Well-Being, Yale University, 2018
- Communicating with Confidence, LinkedIn, 2022-03
LANGUAGES
Arabic
Native or Bilingual
Timeline
Scientist - Complaint Investigation & Resolution
Roche Diagnostics Corporation
12.2022 - Current
Senior Process Development Associate
Codex DNA
03.2020 - 09.2022
Research Associate
Viridos
06.2018 - 03.2020
Technical Lab Assistant
Sharp Chula Vista Hospital
10.2017 - 04.2021
Research Assistant
San Diego State University, Dr
06.2015 - 09.2017
Associate of Science - General Biology
Cuyamaca College
Bachelor of Science - Biology, Cell and Molecular Biology Emphasis
San Diego State University