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Table of Accomplishments

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by

Jason Shaw

on 17 February 2014

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Transcript of Table of Accomplishments

Quality experience in drugs, biologics, and devices
I've worked for and with big and small QMSs
I'm a CAPA nerd
Js
Jason Shaw
Table of Accomplishments
B.S., Chemistry/Biochemistry
Minor: Psychology
Reviewed and approved
nonconforming material
with regard to disposition
education
Earned the nickname
"Eagle Eye"
Responsible for manufacturing
clearance, product sampling &
disposition, and overall product quality
professional experience
2006-2011
Advanced from Quality Associate I
to Quality Associate III
Advanced Quality Technician for sterile
IVD filling/labeling manufacturing
2004 - 2006
Quality Associate I:
Redesigned plant exception management process resulting in reduced time approval of low-risk failures
Created and revised plant SOPs and training materials
Investigated and resolved group nonconformities
Compiled and maintained CAPA Review Board and Management Review metrics
Quality Associate II:
Managed sterile injectables facility change control processes
Collaborated with pharmaceutical partners on improvement initiatives such as a Right First Time Black Belt project
Served as plant representative for receipt and review of supplier changes; led implementation projects
Planned and led internal assessment audits
Quality Associate III:
Computerized System Owner (CSO) of Global Supplier Quality, Supplier Corrective Action and Supplier Audit workflows in globally-deployed TrackWise software platform
Developed and delivered global TrackWise system user training program
Owned and led global-level Corrective and Preventive Action (CAPA) projects
Led and mentored staff of full time employees and contractors in daily operations and through Baxter growth/development processes
2011 - Present
Supplier Quality
Lead Engineer
Leads supplier audits using ISO 9001, ISO 13485, ISO/IEC 62304, and/or 21 CFR Part 820 standards
Coaches and advises strategic suppliers on QMS development and documentation
Represents Supplier Quality as SME on CAPA teams as well as during internal/external QMS audits
Acts as single point of contact for Supplier Quality at Executive reviews, Quality Management Reviews, CAPA Review Boards and during internal/external audits
So...
Why hire me?
strengths
why I'm interested
I'm Technical.
...but I can read my audience
Explaining technical topics in simple terms can be exceedingly difficult

As the owner of the global TrackWise training program, I did it routinely
I work well with all levels
As an auditor I talk to CEOs, Manufacturing techs and everything in between
I have a recognized, accredited skill set
I enjoy the challenge of building something and watching it grow
The breadth of responsibilities are interesting to me and will position me for advancement within the organization
The trio of auditing, management of CAPA, and ability to lead parts of the training program are key parts of my dream job
Thank
you
...and I'm good at presentations
Questions?
I was going to make a PowerPoint presentation like everyone else does
...but I'm not like everyone else
so I made this
As the father of a three year old, I practice every day
What is
blood for?
Full transcript