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Title : SA- Validation Specialist III -874
State : Massachusetts   Date : Jan 9, 2019
Experience Level :  
Position Type : Validation Specialist III      
Description
This position is for a leading pharmaceutical company. Below are the details of the engagement. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP.
Looking forward to hearing from you soon.

Work Location: Allston, MA


Job Title: Validation Specialist III


Duration:  4+ months (extendable) contract on W2


Duties:


QC Instrumentation Services is responsible for the management and implementation of the Laboratory Equipment Qualification system. It's goal to efficiently specify/source laboratory equipment and execute qualifications in a timely manner to enable QC Microbiology and QC Chemistry departments to execute their functions using equipment which meets the intended use. This position is responsible for qualifying computerized instrument associated software used for analytical and microbiological testing at the Genzyme Allston Landing Facility. Responsibilitioes include execution and coordination of activities to qualify software, writing protocols, reports and procedures, coordinating the purchase, commissioning and introduction to the QC laboratory. Establish and maintain Equipment History Files (EHF). Coordinate all services provided by vendors, ensuring vendors meet all site requirements. Schedule/plan/execute validation activities. 


Skills:


Demonstrated scientific technical writing ability. Knowledge of USP 1058 and GAMP methodology. Knowledge of 21CFR Parts 11, 210, 211, 600 and 610 and Annex 11 Previous hands on experience performing software validation compliant with 21CFR Part 11 and Annex 11. Proficient in Outlook, Microsoft Word, and analytical instrumentatin software, e.g. SoftMax Pro. Ability to gown and enter laboratory May require off shift work to support activitie



Education:



Bachelor's Degree in Chemistry, Life Sciences, or Engineering discipline and 5 years of Industry relevant experience Or Master's Degree in Chemistry, Life Sciences, or Engineering discipline and 3 years of Industry relevant experience Minimum of 3 years of experience with analytical testing in a laboratory setting, such as HPLC, GC, Ion Chromatography, TOC, UV-Vis, ELISA.



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Many Thanks,   

Sree Kanth
Associate Recruitment Manager
Sree@newageclinical.com

NewAgeSys, Inc.
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Princeton , NJ 08540 
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