Nathalie Gaudefroy

Tel: 805-***-****

Email: adwgnq@r.postjobfree.com

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Profile

Team oriented leader managing processes, managing systems, mentoring employees, and assisting with sales.

Education

Bachelor of Science, Biology University of California, Santa Cruz 2010- 2013

CORE COMPETENCIES

Proficient in MS Project Manager Tool, MS Office (Word, Excel, Power Point, Visio), SAP, Confluence

Knowledge and working application of GDP, GCLP, FDA/cGMP requirements

Technical Writing • Validation Writing • Regulatory Writing

EXPERIENCE

Illumina, San Diego April 2019-Present

Validation Engineering Project Lead (From Design Control to the regulatory submission)

•Participates in all phases of the project life cycle development with a goal to release new clinical products.

•Coordinates project team meetings and tracks activities; develops, prioritizes and tracks action items and issues.

•Utilizes MS Project Manager to create/maintain project plans showing tasks, resources, dependencies and status.

•Expert SAP documentation and resource for Core Team members.

•Establishes and maintains Design History File (DHF) documentation, device master records (DMR), Bill of Materials (BOM), supplier records, and documentation for regulatory submission.

•Reviews documents for good clinical laboratory practices (GCLP), good clinical manufacturing practice (GMP) and regulatory requirements.

•Processes design control documents using SAP system per established procedures.

Illumina, San Diego 2017-2019

Technical Writer (Regulatory Submission project)

•Managed Technical Writers and trained new employees on the SAP document system.

•Reviewed engineering software verification/validation documents for completion, accuracy, and compliance to Good Documentation Practices (GDP).

•Lead advanced engineering document updates to ensure compliance to CFR 820/Quality System Regulations.

•Translated business requirements into user documentation.

•Reviewed User Requirement Specifications to ensure specification accurately represent goals of the stakeholders.

•Reviewed R&D equipment drawings for completion, accuracy, and adherence to GDP.

•Managed project documents and project deadlines in MS Project Manager.

Abbott, San Diego 2016

Design Control Manager

•Orchestrated cross functional meetings to identify documentation required from inception to new product launch.

•Gained familiarity with CE Mark regulations pertaining to sales of medical products in the European Union, applied them to product packaging and labeling to ensure compliance, and developed documentation required to support the 510K product submissions.

•Authored documents to support 510K product submissions: Validation Test Reports, IQ/OQ, work instructions, Master Validation Plan, Design History File (DHF)

•Adhered to document control style guidelines to ensure consistent quality work

•Managed new personnel and led training in document creation

Genoptix, San Diego 2015

Project Manager

•Worked in conjunction with clinical trial partners and end-users to gather specifications for new clinical trials.

•Documented test methods and verified successful installation of all configuration of clinical test methods in the electronic tracking systems.

•Worked with end users and process owners to collect data to support protocol requirements, analyze data collected and create validation reports.

•Configured clinical studies in LIMS to meet end-user needs and those of the clinical trial partners.

•Authored technical change control/validation documents.

•Collaborated with various departments to execute validation protocols for implementation of new software and new laboratory equipment.

•Support LIMS users by responding to change requests and training needs.

GenMark Dx, San Diego 2014

Document Specialist

•Translated business requirements into user documentation for the release of new IVD products.

•Performed documentation updates related to internal audit findings.

•Provided manufacturing improvements by enforcing increased inspection of IVD kits to reduce non-conformances.

•Managed internal resources to plan and create documentation standards, systems, and content.

•Drove the development and maintenance of product documentation in a timely fashion.

•Authored engineering change orders, deviations and drove changes to completion.

•Coordinated project timelines and document review/revision; initiated cross-functional collaboration with Clinical Operations, new Product Management, Manufacturing, and Regulatory Affairs.

2010-2013: Attended the University of California, Santa Cruz

Dako, Carpinteria 2007-2009

Internship in Cancer Research Lab

•Supported clinical research to analyze cancerous tissues for breast cancer markers and drafted clinical study requirements/objectives.

•Assisted Scientists in lab work to phenotype lymphoma tissues and breast cancer tissues.

•Conducted immunohistochemical testing with DAKO antibodies and instruments.

•Analyzed cancerous cells and tissues and created scientific reports.

Training: Microsoft Word, Excel, Power Point, Microsoft Project, Microsoft Visio, SAP, Master Control, Agile, Visio, Solid Works, LIMS: LabVantage, LabWare

References available upon request.

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