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Title : SA- Documentation Specialist I -961
State : Massachusetts   Date : Oct 19, 2018
Experience Level :  
Position Type : Documentation Specialist I      
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: Westborough, MA


Job Title: Documentation Specialist I


Duration: 11+ months (extendable) contract on W2


Duties:


The role is responsible for working with CMO’s review and approves manufacturing batch records, manage and approve deviations, investigations, and corrective actions related to product release. This position will perform a variety of tasks under general guidance and in accordance with current GMP's. Responsibilities include: Manage product complaints Review and release production batch records Review manage change controls Providing Quality Review and approval of deviations related to Manufacturing Equipment, Facility and production Participating on team to investigate deviations to determine appropriate root cause and CAPAs or may be responsible for CAPA resolution Report metrics and create monthly and quarterly reports. Develop Sop’s as required Performs in accordance with SOP’s, safety and GMP guidelines to support release of finished product Maintain and increase scientific, regulatory and compliance expertise and work with existing QA group to develop organizational and technical capabilities. Be current with various regulatory requirements and procedures.


Skills:


A combination of education, training and experience may be considered in lieu of the above stated qualifications.
2 to 3 years of experience working in a CGMP environment Experience working in Quality in a GMP environment Experience working in a Quality role supporting production Experience with technical writing Ability to operate in an environment with strict timelines Experience performing work that consistently requires decision making and the exercise of judgment and discretion in a CGMP environment Experience demonstrating written and verbal communication skills Experience demonstrating proficiency with Microsoft Office applications


Education:


BS/BA degree in a scientific discipline. 


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Many Thanks,   

Sree Kanth
Associate Recruitment Manager
Sree@newageclinical.com

NewAgeSys, Inc.
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