Loann

Quality Engineer with over 8 years of experience in the biotechnology and pharmaceutical industries, specializing in Quality Assurance and Quality Engineering. Proven expertise in Quality Management Systems (QMS), GMP compliance, CAPA management, and SOP development with a demonstrated ability to implement eQMS and streamline laboratory workflows.

Consultant - Self-Employed - Alameda, CA

(2025-05)

• Design robust Quality Management System (QMS) tools for biotech startups pursuing GMP and ISO compliance.
• Develop custom workflow-management applications using digital tools to improve operational efficiency.
• Build specialized tracking solutions focused on continuous improvement, process standardization, and data flow.

Automation Services Engineer - Eikon Therapeutics - Hayward, CA

(2023-10 - 2025-04)

• Maintained complex laboratory robotics platforms (including Agilent and Echo systems) to support workflow scaling.
• Authored, revised, and optimized cross-functional Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Analyzed service tickets to evaluate root causes, systematically implementing targeted solutions that advanced tool reliability.

Quality Engineer II / Quality Engineer - Freenome - South San Francisco, CA

(2021-08 - 2022-09)

• Authored and implemented over 40 standard operating procedures supporting corporate eQMS buildout and GMP frameworks.
• Wrote comprehensive technical validation scripts to ensure flawless software deployment across enterprise eQMS applications.
• Served as Quality Owner for material management and spearheaded nonconformance investigations to drive corrective actions.

Quality Assurance Analyst - Synthego - Redwood City, CA

(2019-01 - 2021-07)

• Built out the GMP Warehouse and managed the released products.
• Managed Room Release and Line Release for GMP Cleanroom.
• Served as owner of CAPA, deviations, NCR, and incidents for eQMS. Assisted in ISO 9001:2015 certification.
• Worked with cross-functional teams to create new projects for GMP buildout.
• Handled User Testing Validation and implementation for eQMS.
• Revised and created new SOPs for different processes and implemented new trainings in different departments.
• Supported batch record issuance, review, and line/room release.

Senior Research Associate - Synthego - Redwood City, CA

(2019-01 - 2021-07)

• Synthesized oligonucleotides on SSA and AKTA equipment.
• Trained and signed off new laboratory associates; served as lead on weekend shift as needed.
• Worked in manufacturing setting to produce in mass quantities.
• Analyzed UV and mass spec data on Agilent Spectrometer.
• Utilized size exclusion chromatography (SEC) and UV-Vis spectroscopy for purification.
• Operated automated robotic systems to manage liquid products.

Lab Technician 2 - Amyris - Emeryville, CA

(2017-06 - 2019-02)

• Acted as main user of two BenchCel robotics platforms. Gained experience with StacMax, SoftMax, NX, BioCel, and Bishop.
• Maintained all stock HTS and ASE media and plates. Created and maintained SOPs and workflows.
• Performed stitch inoculation for Biology/ASE.

Lab Technician - Genentech - South San Francisco, CA

(2016-06 - 2017-06)

• Took on projects to maintain efficiency and productivity.
• Applied knowledge of LEAN training and 5S methodologies.
• Operated Autoclave, Washer, Dryer, and Pyro Equipment.
• Served as Safety team and Ergonomics team advocate.
• Contributed as a writer for the Engrained Quality newsletter within a GMP environment.

Graduate Certificate - Regulatory Affairs - San Diego State University (2021-07)

Bachelor of Arts - Psychology - San Francisco State University (2017-06)