Documentation Specialist III
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Documentation Specialist III
Ref No.: 15-02628
Location: Framingham, Massachusetts
Start Date / End Date: 10/26/2015 to 01/16/2016
The Quality Control Chemistry Laboratory is seeking a candidate to fill a QC Documentation Specialist position. The individual will be responsible for review of data for completeness in accordance with SOP s, GDP, and regulatory standards. Must possess sound interpersonal and information gathering skills, being able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with others. The analyst may interpret and trend complex data.

The shift is Wednesday-Saturday day shift.
Skills:Basic Qualifications:
Experience with HPLC (reversed phase and gradient) chromatography and Empower software, and 3+ years of direct experience.
QA/QC data review in a regulated industry and 3+ years of experience.
Knowledge of FDA regulations, GDP, and cGMP.

Preferred Qualifications:

Knowledge of SDS-Page, UV-Vis spectrometry (Spectramax plate analysis), and Ion Exchange chromatography (Dionex), a plus.
Education: Degree in the Life sciences discipline, Bachelor degree and 5+ years of experience, or a master degree and 3+ years of experience.
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