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Compliance Specialist / GMP Document Control

Company: Itech Consulting Partners
Location: New Haven
Posted on: September 9, 2020

Job Description:

Job type:--W-2 contractLocation:--New Haven, CTDuration:--6 months--Job OverviewOur client is seeking an experienced--GMP Document Control / Compliance Specialist----who will perform the following duties:Receive and process requests within the company eDMS for controlled document creation, changes, or withdrawal (Document Control, Change Requests).Maintain tracking and processing of controlled documents relating to company Periodic Review process.Maintain the system for records and retention using a standard categorization system in accordance with internal and regulatory requirements.Receive and respond to requests for Quality Documents / Records / Revision History during internal and/or Regulatory Audits.--Skills and Qualifications:Minimum of 7 years GMP related experience in biopharmaceutical / pharmaceutical or related industry.Experience in developing, implementing, and evaluating archives or records management processes and systems.--This includes cataloging, filing, and retrieving of records.Experience with GMP / CGMP/FDA global regulatory requirements.Experience with electronic document systems(eDMS, e.g. FirstDoc and TrackWise) and databases.--Capable of moving, copying and recovering large numbers of files and folders in a Windows environment.Knowledge of the creation and management of records retention schedulesKnowledge of archival metadata and metadata managementAbility to work in a fast-paced environmentEducation BS/BA degree in Chemistry, Biology or related fieldOther keywords: Compliance, Quality Assurance, Document Control, Change Control, MS Excel

Keywords: Itech Consulting Partners, New Haven , Compliance Specialist / GMP Document Control, Other , New Haven, Connecticut

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