SUNIL SAINI
Lathrop,CA
Summary
Detail-oriented biotech operations professional with a track record of eliminating data errors, improving processes, and supporting cross-functional teams in regulated environments. Experienced in data verification, documentation accuracy, workflow standardization, and developing automated tools that enhance reliability and throughput. Known for clear communication, fast learning, and translating complex procedures into usable, consistent operational practices.
Overview
5
5
years of professional experience
Work History
Quality Control Analyst
Cepheid
09.2024 - Current
- Developed an automated DHR verification tool that eliminated data entry errors and ensured compliance, driving near 100% accuracy before QA submission.
- Designed a String Generator tool that eliminated critical lot information errors, achieving 0% errors and ensuring all documentation systems fully supported compliance and accurate reporting.
- Led data verification and validation processes for high-volume molecular assay operations, sustaining zero operator errors over 12 consecutive months in a regulated environment.
- Collaborated cross-functionally with QC, QA, and Operations teams to standardize workflows, manage process changes, and ensure consistency across systems.
- Rapidly onboarded to and supported 20+ complex procedures, demonstrating adaptability and the ability to manage accuracy under shifting operational priorities.
Data Analyst
Hologic
03.2023 - 09.2023
- Identified and corrected approximately 100 data inconsistencies across 80+ validation reports, ensuring regulatory compliance and accuracy.
- Performed root-cause analyses on customer complaints to support product performance and uphold assay claims.
- Translated complex data findings into clear documentation for internal teams, supporting decision-making and external reporting.
Clinical Laboratory Technician
Helix
08.2021 - 11.2022
- Created a cost-free automated method, increasing sample verification speed by 12x, quadrupling capacity, and enhancing accuracy.
- Authored SOPs for viral surveillance to standardize procedures and ensure consistency.
- Trained and mentored new hires to excel in fast-paced laboratory environments.
- Created visual job diagrams to streamline workflows and reduce variability across processes.
Education
B.S. - Biological Sciences
University of California, Davis
Davis, CA06.2020
Skills
- Data verification methods
- Data governance
- Data analysis
- Advanced Excel and Minitab
- SOP development
- Training and documentation
- Process visualization techniques
- Cross-functional collaboration
- Change management
- Problem-solving skills
- Quality assurance practices
- Good manufacturing practices
- Laboratory Information Management Systems
- GeneXpert and QuantStudio7
Timeline
Quality Control Analyst
Cepheid
09.2024 - Current
Data Analyst
Hologic
03.2023 - 09.2023
Clinical Laboratory Technician
Helix
08.2021 - 11.2022
B.S. - Biological Sciences
University of California, Davis