Quality Systems Specialist - MilliporeSigma - Rocklin, CA
(2024-06 - 2026-02)
- Coordinated post-market surveillance and vigilance activities, including adverse event tracking and complaint trending for over 400 products annually, reducing regulatory risk and improving product safety.
- Developed and executed PMS plans, procedures, and reports (PSURs/PMSRs), performing data collection, analysis, and reporting, in compliance with EU IVDR/MDR, MDSAP, FDA QMSR, and internal QMS requirements.
- Monitored and analyzed post-market data from customer feedback, complaints, field corrective actions, and literature reviews, performing trend analysis to identify potential improvements, safety concerns, and determine market performance.
- Partnered cross-functionally with R&D, Medical Office, Regulatory, and Risk Management to assess impact of field actions, perform root cause analysis, and support risk mitigation strategies, facilitating implementation of CAPAs resulting from PMS findings.
- Authored, reviewed, and approved technical documentation for regulatory submissions, in alignment with design control and risk management principles. Worked with internal stakeholders to identify, escalate, and resolve quality issues, while recommending or initiating solutions for continuous improvement.
- Supported internal and external audits by providing PMS documentation, regulatory rationale, and evidence of compliance with Medical Device regulations and guidelines, including EU IVDR/MDR, MDSAP, ISO 13485, ISO 14971, FDA 21 CFR 820, MDCG, IMDRF, and more.
Ag Biologicals Engineer II - Ginkgo Bioworks - West Sacramento, CA
(2022-10 - 2023-08)
- Managed the BIOVIA Electronic Laboratory Notebook (ELN) system, improving data integrity and user compliance through training, audit support, and vendor coordination.
- Implemented data governance practices by building knowledge repositories in Confluence and managing project workflows in JIRA.
- Collaborated cross-functionally to establish documentation standards policy. Evaluated commercial ELN platforms through sandbox testing and vendor demos, supporting enterprise-level system selection.
- Drove adoption of automation technologies by leading educational workshops, developing training materials and instructional guides, documenting best practices, and providing troubleshooting support. Created and maintained the Tecan Wiki space in Confluence, enabling knowledge capture and retention.
- Improved automation efficiency by developing and optimizing liquid handler scripts, reducing processing time and increasing reproducibility.
R&D Specialist III - Bayer Crop Science - West Sacramento, CA
(2015-12 - 2022-10)
- Contributed to site-wide automation strategy as part of the Automation Core Team, by scoping new technologies, integrating existing platforms, and identifying system gaps, enabling faster deployment of automation solutions and improving operational efficiency.
- Executed high throughput LC-MS assays, including method development, data analysis, and reporting within LIMS and ELN systems, shortening turnaround time while delivering reliable data for downstream decisions.
- Authored and updated SOPs for new analytical methods, while managing review and documentation processes for assigned assays, ensuring consistency, traceability, and compliance.
- Reduced downtime by troubleshooting and performing routine maintenance on LC-MS and liquid handler automation systems.
Bioanalyst II - Eckert & Ziegler Vitalea Science - Davis, CA
(2015-05 - 2015-09)
- Performed bioanalytical testing in compliance with production and quality standards.
- Supported audit readiness by maintaining laboratory systems and collaborating with QA on compliance activities.
Senior Research Associate II - Gilead Sciences, Inc. - Foster City, CA
(2014-09 - 2015-04)
- Supported early-phase drug development by developing, optimizing, and executing analytical methods and stability studies for Phase I/II clinical products.
Chemist - Ampac Fine Chemicals - Rancho Cordova, CA
(2005-06 - 2014-08)
- Applied cGMP, ICH, and USP standards to development, validation, technical transfer, and qualification of analytical methods, ensuring accuracy and reliability of R&D and QC testing procedures.
- Authored, reviewed, and approved protocols, reports, SOPs, and specifications in MasterControl, maintaining regulatory compliance and data integrity.
- Managed the Reference Standards program, including procurement, tracking, qualification, proper use, and storage of all reference standard inventory, in support of QC operations.
- Performed peer-review of analytical data and laboratory reports, verifying accuracy, consistency, and regulatory compliance.
