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Senior Quality Assurance Compliance Specialist (97C)

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Location
New Haven, CT
Job Type
Contract
Degree
Bachelor
Date
Nov 20, 2018
Job ID
2641309

Description

Our client is seeking a Senior Quality Assurance Compliance Specialist who will assist in daily activities for the ongoing development and operations of the Country Quality QMS optimization project. the successful candidate will carry out the operational requirements that result from policies, procedures, regulations, and guidance governing the management of records that exist in print and electronic form.  This role will help manage the electronic documentation of records, liaise with other internal/external Document Management and Country Quality support staff, and the management of QMS Optimization project plan activities.

 

Job type: W-2 contract

Duration: 9 months

Location: New Haven, CT

 

Skills and Qualifications:

·       Minimum of 7 years GMP related experience in biopharmaceutical / pharmaceutical or related industry.

·       Experience with electronic systems (e.g. FirstDoc and TrackWise) and databases.  Capable of moving, copying and recovering large numbers of files and folders in a Windows environment.

·       Experience in developing, implementing, and evaluating records management processes and systems.  This includes cataloging, filing, and retrieving of records.

·       Experience with GMP global regulatory requirements

·       Education: BS/BA degree in STEM related field of study preferred; will consider a commensurate level of education and exp

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