Quality Assurance/ Quality Management/ Regulatory Affairs

Yolynar Boillet

*******.*******@*****.***

Sunnyvale, CA

EDUCATION

**** – 2015 Regulatory Affairs Certificate

University of California Santa Cruz Silicon Valley Extension (Santa Clara, CA, USA)

2007 - 2008 Bachelor Degree in Organizational Management Major in Quality Management Université Pierre Mendes – France (Grenoble, France)

2000 - 2002 Bachelor of Science: Specialization in Cell and Molecular Biology Concordia University (Montreal, QC, Canada)

WORK EXPERIENCE

02/2015 – Present Quality Assurance (QA) Associate Kamet, a manufacturing company for precision component machining and subassembly services for the Aerospace, Energy, Medical and Semiconductor industries (Milpitas, CA)

Project management - Responsible for planning, validation and implementation of the transition to paperless and Real-Time Statistical Process Control (SPC)

Manage the day-to-day operational aspects of SPC

Perform data analysis and corrective and preventive actions (CAPA)

Participate in internal, customer, ISO and supplier audits

Responsible for Equipment Calibration Process

Create and update Quality Procedures

Participate in Change Control Process (Engineering Change Requests)

Participate in Operations Review

Create and maintain metrics

Perform trend analysis and participate and implement process improvement

Process customer complaints

Provide training

04/2010 - 09/2012 Operation and Marketing Manager

Start-up of Ganda.fr, a retailing and e-commerce company (Grenoble, France)

Designed, imported, and sold pearl jewelries

08/2008 - 12/2009 QA Assistant Manager

Technidata, a company providing software solutions for laboratories and biorepositories Updated and managed the QA management system (Montbonnot, France)

Assisted in creation and update of Quality Manual, procedures, and standard operating procedures

Prepared quality metrics and organized management review meetings

Performed audits and followed up on audit corrective actions

Facilitated the corrective and preventive actions (CAPA) process

Maintained non-conformities and complaints database

Provided training on QA-related topics to different departments

Reviewed documentation prior to new product release

Participated in the definition, development, and implementation of continuous improvement process

Translated documents from French to English

10/2007 - 06/2008 QA Assistant Manager (training)

Duhamel, producer of electronic information displays (Electronic Newspapers, On-board passenger information, and LED screens) (Domene, France)

Updated the QA system

Conducted supplier and internal audits

Assisted in the creation of Key Performance Indicators

Processed customer complaints

Assisted and tracked resolutions of quality problems

Created supplier performance indicators

04/2004 - 10/2007 Quality Control Technician

SATMA, manufacturer of aluminum foil for electrolytic capacitors (Goncelin, France)

Managed laboratory routine activities and performed quality control testing

Processed customer complaints

10/2003 - 03/2004 Quality Control Technician

Pechiney, manufacturer of aluminum foil packaging (Froges, France) 07/2002 - 12/2002 Quality Control Analyst

KABS Laboratories, a company providing drug products analysis (St Hubert, Canada)

Conducted tests to verify compositions of a variety of medicine and supplements according to US Pharmacopeia (USP), British Pharmacopoeia (BP) and National Formulary (NF) under the cGMP guidelines

Followed protocols (PCR, Southern blot, cell culture, ELISA, electrophoresis Preparation of reagents and materials for experiments

(HPLC, GC, atomic absorption, IR, dissolution Utilization of instruments

(Centrifuge, microscope, spectrophotometer, pH meter, polarimeter

01/1999 - 04/1999 Tutor Biology and Chemistry (Montreal, QC, Canada)

LANGUAGES / SKILLS

Languages English, French, Tagalog

Skills Regulatory Affairs:

Familiarity with GCP’s, GLP’s, GMP’s, IND, NDA/BLA, 510k/PMA, IDE. Quality Assurance Management:

Application of standards (ISO 9001/2000, ISO 13485 management system for the design and manufacture of medical devices, ISO 14971:2007 Medical devices -- Application of risk management to medical devices, IRIS International Railway Industry Standard). Audits (Internal and Supplier). Training. Statistics. Risk Analysis (Failure Mode Effects Analysis (FMEA)), Use of Quality Management and Process Improvement tools and methods (Root cause analysis, PDCA, Pareto chart, Histogram, Flow charts, SPC

Computer software:

Adobe Acrobat, Adobe Photoshop, MS Access, MS Excel, MS Outlook, MS PowerPoint, MS Project, MS SharePoint, MS Visio, MS Word, Minitab, WINSPC.

CERTIFICATES

March 2014 Design and Interpretation of Clinical Trials – Coursera August 2014 Clinical Terminology for International and U.S. Students – Coursera

EXTRA CURRICULAR ACTIVITIES

Sports Hiking, trekking, running (road, trail), alpine and cross country skiing, snowboarding, yoga.

Music and arts Piano, guitar, ukulele, dance, photography.

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