While adept at various methods of System Validation, my specialty is Pharmaceutical Validation, with focus on clinical trials, late phase, facility activation and standards and practices editing.

Starting with Ontario Systems, where I worked with Medical Records and Electronic Signature management, I became a journeyman in the field working with Eli Lilly on several 21 CFR Part 11 projects. I took this knowledge to assist a process audit for Disetronic, and with REGISTRAT-MAPI have completed over fifty separate 21 CFR Part 11 related Validation Efforts. From there, I validated 32 new Fermentation Units for the Elanco Clinton Plant, along with various other facility validation intiatives. Immediately thereafter I worked with the Global Quality Services Organization of Eli Lilly, processing and editing Global and Local standards, practices, references and resources.

All of these engagements have given me a robust skill set in pharmaceutical validation and electronic record management -- my skill in Regulus has no peer.

At any given time in my career, I've always been involved in System Validation: the cradle-to-grave quality assurance for any system, internal or external.

I am adept at all stages: cataloguing System Requirements, documenting Validation Plans, designing and executing Installation, Operational and Performance Qualifications, performing industry process assessments, evaluating deviations and anomalies, and documenting the entire process in a complete Validation Report. I am equally comfortable working with a team, or performing the entire effort by myself.

As an honors graduate of the University of Colorado's debut year of their Technical Communication program, I designed my program to draw from every discipline in technical writing. Using a simple, yet elegant writing style, I can appeal to the target audience and make the most daunting technical task accessible and comfortable.

I have completed technical writing projects for Hapwood Hardware, StarTek Incorporated, Robbins and Tyler and J&B Enterprises. These projects have ranged from simple usability guides, to internationally-translated procedure diagrams, to greeting and protocol scripts for foreign-language callers.

Software documentation has long been my first passion in technical writing. As a devoted technophile and hobby programmer, software documentation is of course my preferred medium. A good user manual not only instructs the user, but empowers them, and gets them excited about the software that is now at their fingertips.

I have completed over two hundred separate professional software documentation projects, including user end documentation (both online and hard copy) for Lucent Technologies, Avaya, Ontario Systems, Pinnacle Systems, Endless Paths Software, Homeboy Software, Galahad Publishing, Exstream Software and REGISTRAK-MAPI. I am equally adept at working with a team or doing the entire suite by myself.

My first Graduate-level internship with Lucent Technologies put me with the ISO 9000 audit team. Under their tutelage, I learned every aspect of this International Process Standard -- from writing procedures, to compliance, to audit preparation, to the procedures involved in an ISO audit.

Thus, I worked extensively with Lucent Technologies on ISO 9000 and 9001, both drafting procedures and leading symposiums on process. I also did ISO procedure drafting for Ontario Systems and Exstream Software.