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Loann User

@loannuser

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Experienced quality engineer specializing in automation for biotech.

United States

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What I'm looking for

I seek a growth-minded company where I can lead automation-focused quality efforts, drive eQMS validation and training, and improve GMP processes through cross-functional collaboration and continuous improvement.

I am an experienced Quality Engineer with 8+ years in the biotechnology sector focused on automation services, GMP operations, and eQMS implementation. I have led automation platform integration, maintained robotic systems (Agilent, Echo), authored and revised SOPs/WIs, owned CAPA/NCR/deviation processes, and supported room and line releases to improve system reliability and operational productivity.

I collaborate cross-functionally to deliver validation, training, and process improvements—building GMP warehouses, developing training modules in Adobe Captivate, implementing eQMS validation scripts, and assisting ISO certification efforts. I am detail-oriented, motivated, and seeking a role at a growth-minded company to expand my impact in automation and quality systems.

Experience

Work history, roles, and key accomplishments

Quality Engineer

Eikon Therapeutics

Oct 2023 - Apr 2025 (1 year 6 months)

Maintained and integrated automation platforms and robotics (Agilent, Echo), authored and revised SOPs/WIs, and analyzed service requests to reduce recurring system issues and improve lab productivity.

Agilent SOP WI Authoring Troubleshooting Documentation

Quality Engineer II

Freenome

Aug 2021 - Sep 2022 (1 year 1 month)

Owned nonconformance management and LMS training during eQMS implementation, wrote validation scripts, SOPs and WIs, and managed material control to improve compliance and training completion rates.

EQMS Validation SOP WI Authoring LMS Adobe Captivate Quality Assurance Material Management Training Development

Quality Assurance Analyst

Synthego

Jan 2019 - Jul 2021 (2 years 6 months)

Built GMP warehouse processes, led room and line release activities, owned CAPA/deviations/NCRs and supported ISO 9001:2015 certification and eQMS validation to strengthen quality systems.

CAPA Deviations Room Line Release ISO 9001 User Acceptance Testing Cross Functional Collaboration

Lab Technician II

Amyris

Jun 2017 - Feb 2019 (1 year 8 months)

Operated automated and bench robotics, maintained media and plate stocks, and created SOPs and workflows to support high-throughput synthesis and purification operations.

HTS Plate Prep Aseptic Technique SEC Inventory Management

Lab Technician

Genentech

Jun 2016 - Jun 2017 (1 year)

Supported GMP cleanroom operations including room and line release, equipment operation (synthesizers, AKTA), and contributed to safety and ergonomics initiatives to maintain production efficiency.

Room Line Release Synthesizers Autoclave Operation Equipment Maintenance Safety