GxP Document Control Specialist

GxP Document Control Specialist - Contract - New Haven, CT

Proclinical is seeking a GxP Document Control Specialist for our client based in New Haven, CT.

Primary Responsibilities:

The successful candidate will serve as the primary point of contact for on-site GxP records archiving. This role involves managing GxP archives, including receiving and logging archive requests, retrieving records from internal customers, and coordinating with our records vendor to archive records. The specialist will also manage the Enterprise Archiving & Retention business-process and associated processes, and provide excellent customer service support for service requests related to ECMS, Document Management processes, Audit and inspection requests.

Skills & Requirements:

• Bachelor's degree required (Science preferred, Business and other disciplines considered).
• Experience with electronic QMS applications including Veeva Vault Quality, TrackWise, ServiceNow, FirstDocs, Microsoft Office Applications, etc.
• Experience in developing, implementing, and evaluating archives or records management processes and systems.
• Ability to catalog, file, and retrieve records, and create and manage record retention schedules.

The job title responsibilities will be:

• Manage GxP Archives.
• Handle the Enterprise Archiving & Retention business-process and associated processes.
• Manage Lab Notebook/Logbook processes in collaboration with the Analytical Sciences lab onsite.
• Verify controlled documents within the Veeva Vault Quality Enterprise Content Management System (ECMS) for compliance to procedures.
• Provide customer service support for service requests related to ECMS, Document Management processes, Audit and inspection requests.
• Serve as a subject-matter-expert (SME) for Document Management, ECMS, Good Documentation Practices/ALCOA+, Data Integrity/Data Compliance, and other areas as assigned.

If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at s.briggs@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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