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Quality Assurance Compliance Specialist IV

Company: Experis
Location: New Haven
Posted on: June 22, 2020

Job Description:

A Major Pharmaceutical Client is Looking for a Talented Quality Assurance Specialist in eDMS 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 andor Regulatory Audits. - Track and maintain metrics for Periodic Review and all other departmental metrics. - Collaborate with TrainingLearning function to ensure proper assignment of training requirements for controlled document updates andor new releases. - Conduct instructor led trainings for Document Management procedures and routinely consult with internal customers to answer questions, resolve technical issues, and to ensure priorities are met. - Create and distribute Lab notebooks, binders, and other critical documentation in accordance with internal procedures and cGMP, cGLP. - Reference and take involvement in company Deviations, Corrective and Preventive Actions (CAPAs), and Risk Assessments as it relates to Document Control procedures. - Work as part of a team to manage changing priorities, complete tasks, and meet deadlines. Other assigned projects as needed. Skills 9+ Years of Experience - 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 global regulatory requirements. - 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. - Knowledge of the creation and management of records retention schedules - Knowledge of archival metadata and metadata management - Ability to work in a fast-paced environment - Performs a variety of tasks English (Speak, Read, Write) Keywords Education BSBA degree in Chemistry, Biology or related field Skills and Experience Required Skills COMPLIANCE SPECIALIST QUALITY ASSURANCE Languages English Read Write Speak Education Minimum Degree Required Bachelor's Degree Languages English Read Write Speak Experis is an Equal Opportunity Employer (EOEAA)

Keywords: Experis, New Haven , Quality Assurance Compliance Specialist IV, Other , New Haven, Connecticut

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