Nathalie Gaudefroy Email & Phone Number | Biotechnology professional with a track record creating documentation including but not limited to the following: -IQ, OQ, PQ validation documents. -Cleaning validation documents and laboratory reports. -Validation Reports. -Validation deviations. -Trainings for over 300 Manufacturing personnel on validation concepts, Process Performance Qualification (PPQ) training, validation of new products & validation execution strategies using ValGenesis software applications. -Initiated Non Conformances (NCR) and CAPA documentation. -Created SOP, Work Instructions, Quick Reference Guides. -Developed Troubleshooting guides for software and systems. -Created checklists for easy navigation through SAP PLM -Created and revised Instrument Manuals. -Developed and revised Equipment specifications. -Initiated Calibration documents. -Initiated and revised System Software documentation to correct compliance violations. -Created improvements in LIMS software to maintain compliance with FDA regulations and ISO Part 11 compliance. -Created LIMS reports to review data and ensure compliance to ISO 13485 standards. -Led training of OJTs on audit findings and provides solutions to close compliance gaps. -Created Training storyboards & Training presentations on Manufacturing laboratory gowning procedures. -Collaborated with stakeholders to develop Product Specification documentation to support a 510k. -Created Product Marketing material and generated 22% increase in sales by running promotions of products. -Initiated and revised Design Control Documents to support a 510k. Efficiently manages multiple projects, brings a Quality mindset to train new Technical Writers, develops documentation for manufacturing and validation of systems, processes, as well as software and facilitates collaboration with stakeholders to drive projects to completion on time. Open to new challenges and opportunities.

Nathalie Gaudefroy

Biotechnology professional with a track record creating documentation including but not limited to t...
Encinitas, Encinitas, United States

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Nathalie Gaudefroy’s Email nathalie.g@illumina.com

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Nathalie Gaudefroy’s Location Encinitas, Encinitas, United States

Nathalie Gaudefroy’s Current Industry Nucleus Biologics

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Work Experience

Nucleus Biologics

Validation Engineer

2024-06-01 00:00:00 - Present

Pina Publishing

Marketing Director

2023-02-01 00:00:00 - 2024-07-01 00:00:00

Illumina

Validation Engineer Technician 4

2020-09-01 00:00:00 - 2024-07-01 00:00:00

Alere

Design Engineer

2016-02-01 00:00:00 - 2017-01-01 00:00:00

Genoptix

Laboratory Analyst

2015-01-01 00:00:00 - 2015-11-01 00:00:00

Genmark Diagnostics

Documentation Specialist

2014-03-01 00:00:00 - 2014-08-01 00:00:00

Genentech

Laboratory Technician

2013-01-01 00:00:00 - 2014-01-01 00:00:00

Dako

Cancer Research Internship

2007-01-01 00:00:00 - 2009-07-01 00:00:00

Skills

No Skills Available

Languages

No Languages Available

FAQ About Nathalie Gaudefroy

Nathalie Gaudefroy is located at
Encinitas, Encinitas, United States

Nathalie Gaudefroy is a Biotechnology professional with a track record creating documentation including but not limited to the following: -IQ, OQ, PQ validation documents. -Cleaning validation documents and laboratory reports. -Validation Reports. -Validation deviations. -Trainings for over 300 Manufacturing personnel on validation concepts, Process Performance Qualification (PPQ) training, validation of new products & validation execution strategies using ValGenesis software applications. -Initiated Non Conformances (NCR) and CAPA documentation. -Created SOP, Work Instructions, Quick Reference Guides. -Developed Troubleshooting guides for software and systems. -Created checklists for easy navigation through SAP PLM -Created and revised Instrument Manuals. -Developed and revised Equipment specifications. -Initiated Calibration documents. -Initiated and revised System Software documentation to correct compliance violations. -Created improvements in LIMS software to maintain compliance with FDA regulations and ISO Part 11 compliance. -Created LIMS reports to review data and ensure compliance to ISO 13485 standards. -Led training of OJTs on audit findings and provides solutions to close compliance gaps. -Created Training storyboards & Training presentations on Manufacturing laboratory gowning procedures. -Collaborated with stakeholders to develop Product Specification documentation to support a 510k. -Created Product Marketing material and generated 22% increase in sales by running promotions of products. -Initiated and revised Design Control Documents to support a 510k. Efficiently manages multiple projects, brings a Quality mindset to train new Technical Writers, develops documentation for manufacturing and validation of systems, processes, as well as software and facilitates collaboration with stakeholders to drive projects to completion on time. Open to new challenges and opportunities.

Nathalie Gaudefroy currently works in the Nucleus Biologics |

No Languages Available

Nathalie Gaudefroy has prior
experience in the following industries:
Pina Publishing | Illumina | Alere | Genoptix | Genmark Diagnostics | Genentech | Dako

Nathalie Gaudefroy has the following professional experience:
Nucleus Biologics | Pina Publishing | Illumina | Alere | Genoptix | Genmark Diagnostics | Genentech | Dako