*Please respond back to sate...@protegellc.com <sate...@protegellc.com> or
call me on 703 596 1600 x 104.*

*Job Title: Quality Systems Specialist*
*Location: Lexington, MA *
*Duration : 6 Months*

*Education and Experience Requirements *
College degree preferred
Experience with Quality Systems required
Change Control, CAPA and Deviation experience related to GMP / GDP /
Medical Device preferred

*Must Haves:*
Deviation Experience
Trackwise Experience
Communication skills (mentioned above)
Detail Oriented
Advanced Excel Skills (pivot tables/formulas)
Pharma/GMP Experience necessary (biotech, pharma, med device all
acceptable) as long as they have GMP

*Note from Manager*
Candidates can come from any type of quality role
Not looking for new graduates or internship experience-candidates need at
least 5 years of post-grad within Pharma/GMP environment.
Role is open due to transition in the Quality Systems group-team manages
metrics on Trackwise system. They need to know what they are looking at
when they join Shire.
Looking for support through the end of the year
Become a contract position due to not having perm headcount due to current
Shire integration
Team needs someone that has really strong experience with Trackwise (Shire’s
computerized system used for Quality systems) used for Capa’s & Deviations
Need Experience with Deviations & Root Cause Analyses
Solid Written and Verbal Communication Skills
Details and Project Oriented
Write Clearly and speak Clearly-must be able to write and read and speak
clearly in English
Will support Hiring Manager in Deviation Process
Support Kappa and Change Control process Owners
Ideally Have Training Experience within Quality Systems (designing
training, presenting)-Nice to Have
Degree Preferred-experience can balance this out.

*Thanks & Regards*
*Sateesh | Lead Technical Recruiter*
*Protege, LLC.*
*12020 Sunrise Valley Dr, Suite 100, Reston VA 20191*
*Email: sate...@protegellc.com <sate...@protegellc.com> | Gtalk:
recruiter.sateesh*
*Office: 703 596 1600 x 104; Fax: 877 481 9005*
*Visit us at: www.protegellc.com <http://www.protegellc.com>*

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