Trainer/Tech Writer Resumes in US-California-Silicon Valley/San Jose: connie

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Contact Candidate

Name:

connie

Location:

US-California-Silicon Valley/San Jose

Experience:

Willing to Relocate:

Willing to Travel:

Most Recent Job Title:

Trainer/Tech Writer

Personal Website:

Objective:

to be a project coordinator in marketing, quality, documentation or research in a medical device, pharmaceutical or software company in the bay area.

Resume Text:

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Skills and Experience
·         10 years experience as Technical Writer - QA Specialist in a medical device and biotech industries with a BS Math/Chemistry degree
·         10 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 2007 – present
Edits, formats and reviews Instructor and Student Guides for Network Appliance University, Sunnyvale (Software Company)
Aug 2007 – Dec 2007
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 2006 – Aug 2007
Wrote training materials for Deloitte In, Oakland

Jan 2004 – Aug 2006
CAPA Specialist and Validation Protocol Systems Dev Coordinator/Trainer at Roche Systems Inc
Performed quality review of drug safety
July 2003 – Jan 2004: Pharmacy Technology Instructor, Silicon Valley College and
Bryman College
Taught chemistry, anatomy and drug pharmacology
Performed quality review of drug safety

July 2002 – July 2003: Trainer/Speaker, Motherhealth Inc
Women's health speaker and trainer for Motherhealth Inc
May 2001 – May 2002: 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 510k 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 2001 – May 2001: Sr Technical Document Specialist, Inhale, (contract, now Nektar)
Wrote design description documents for Inhale based on their JD Edwards application.
May 1999 – June 2000: 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 1 Customer Support Specialist and 1 technical writer.
Tested the software product and performed other software QA functions.
May 1998 – May 1999: 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 1993 – Dec 1995: 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 1992 – Jan 1993: Training Manager, Dynavision, consultant (Mfg)
Coordinated Motorola in-house Quality Audit, SPC Training and Video Product Marketing and Sales.
Supervised 2 QA Specialists and 2 Document Control Specialists.
Jan 1988 – Jan 1991: Training Manager, Acer Inc. , permanent (Mfg)
Supervised training specialist and developed training programs for the SPC project at Acer
Mar 1983 – Dec 1988: Statistical Process Control (SPC) Training Officer at Intel, (Mfg)
Coordinated Product Transfer, SPC and Cadet training.
Jan 1982 – Dec 1983: Medical Representative, Nattermann Phil., consultant
Training:
Software Engineering: Acer
NetAppU SnapVault 2.5day training , 2008
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