Trainer/Tech Writer Resume
Education: B.S. Math/Chemistry, Adamson University
Expertise
· Desktop publishing: Framemaker, MS Word, Acrobat, MS Office
· Graphics: Illustrator, Photoshop, Visio
· Operating systems: Windows, UNIX
· Document control: Livelink
· Others: RoboHELP, Dreamweaver, Basic, Snagit, Ventura Publisher, Captivate, Metricsthatmatter
Skills and Experience
· years experience as Technical Writer - QA Specialist in a medical device and biotech industries with a BS Math/Chemistry degree
· years self-employed technical writer working with software and manufacturing companies, medical device and biotech industries writing the following:
— Technical manuals, SOPs, specifications and other controlled documents
— Datasheets., Study Reports, Test and System/Software Validation Protocols, Test Plans, Software Design Documents
— Hardware and Software Specifications and User's Guides
— Familiarity with databases, storage, PC motherboards, graphics processors, Ethernet, Sun servers, reference board designs, set-top boxes, hard disk drives, wireless routers
Work Experience
Dec – present
Edits, formats and reviews Instructor and Student Guides for Network Appliance University, Sunnyvale (Software Company)
Aug – Dec
Wrote QA documentations (QA Manual, Document Control SOPs, presentation materials for Design Control, CAPA, and Validation) for Pelikan Technologies, QA Dept in Palo Alto
Performed
Performed quality review of drug safety
Aug – Aug
Wrote training materials for Deloitte In, Oakland
Jan – Aug
CAPA Specialist and Validation Protocol Systems Dev Coordinator/Trainer at Roche Systems Inc
Performed quality review of drug safety
July – Jan : Pharmacy Technology Instructor, Silicon Valley College and
Bryman College
Taught chemistry, anatomy and drug pharmacology
Performed quality review of drug safety
July – July : Trainer/Speaker, Motherhealth Inc
Women's health speaker and trainer for Motherhealth Inc
May – May : Quality Systems Specialist/Trainer, Applied Biosystems/Celera Diagnostics (consultant)
Responsible for making sure that all QA/Regulatory Affairs documents/SOPs/
Manufacturing Procedures comply with Quality System Regulations for Medical Devices. Performed internal QA audits, QA functions such as batch checking and writing discrepancy reports.
Facilitated k submissions. Document troubleshooting activities, corrective, and preventative action plans, and follow up activities associated with incoming or in process nonconforming materials.
Initiated deviation and non-conforming reports and coordinated the timely completion of all proposed corrective actions.
Wrote validation protocols: process, method and equipment.
Jan – May : Sr Technical Document Specialist, Inhale, (contract, now Nektar)
Wrote design description documents for Inhale based on their JD Edwards application.
May – June : Quality Assurance Manager/Trainer, Ingenuus.com (permanent, S/W company)
Wrote press releases, technical support documents, training materials, User's Manual, Reference Manual for Document Change Management system. Handled customer complaints and product deviations. Performed internal QA audits.
Supervised Customer Support Specialist and technical writer.
Tested the software product and performed other software QA functions.
May – May : Quality Systems Specialist, LifeScan Inc. (consultant, Medical Device)
Responsible for making sure that all Information Systems documents/Software Functional Specifications comply with Quality System Regulations for Medical Devices. Performed internal QA audits.
Jan – Dec : QA Specialist, Abbott Diagnostics, permanent (Medical Device))
Responsible for making sure that all Engineering documents comply with cGMP standards and product launches. Performed internal QA audits.
Feb – Jan : Training Manager, Dynavision, consultant (Mfg)
Coordinated Motorola in-house Quality Audit, SPC Training and Video Product Marketing and Sales.
Supervised QA Specialists and Document Control Specialists.
Jan – Jan : Training Manager, Acer Inc. , permanent (Mfg)
Supervised training specialist and developed training programs for the SPC project at Acer
Mar – Dec : Statistical Process Control (SPC) Training Officer at Intel, (Mfg)
Coordinated Product Transfer, SPC and Cadet training.
Jan – Dec : Medical Representative, Nattermann Phil., consultant
Training:
Software Engineering: Acer
NetAppU SnapVault .day training ,
Software Product Life Cycle and Quality Standards: Lifescan
Good Manufacturing Practices and Quality Audit and Compliance Class at
Abbott Diagnostics
Quality System Regulations for Medical Devices: Applied Biosystems
Engineering Designs and Intel Statistical Process Control: Intel
Member: American Society for Quality
Books Authored: Birthing Ways, Healing Ways (ebooksonthe.net) ; www.amazon.com
