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Document Control & Training Manager

Document Control & Training Manager

Enigma SearchAlameda, CA, United States
Hace 20 horas
Tipo de contrato
  • A tiempo completo
Descripción del trabajo

About the job Document Control & Training Manager

Join a Leading Cell & Gene Therapy Company as a Document Control & Training Manager!

Are you a highly organized and detail-oriented Quality Assurance professional with a passion for building robust document control and training systems? Our client, a leader in cell and gene therapy manufacturing, is seeking a Document Control & Training Manager .

This is a fantastic opportunity to join a fast-paced environment where you will lead and implement document management and training processes from the ground up, ensuring full compliance with GxPs and supporting life-saving therapies. If you are a hands-on professional with expertise in Veeva QualityDocs and a knack for cross-functional collaboration, we want to hear from you.

What You'll Work On

In this pivotal role, you'll be the go-to expert for all things related to document control and training. Your responsibilities will include :

  • Managing and coordinating all document control activities and processes for the quality and manufacturing organizations.
  • Leading compliance and continuous process improvement efforts within the Document Control framework.
  • Overseeing the entire document lifecycle, including processing, formatting, and issuing documents for training, ensuring accuracy and efficiency.
  • Supporting the reconciliation and archiving process for all paper documents.
  • Reviewing Document Change Controls to ensure proper revision control and closure.
  • Managing the document periodic review process and coordinating with stakeholders for timely completion.
  • Performing Business Administrator activities in the electronic document management system ( Veeva QualityDocs ).
  • Executing user test scripts for system changes in the EDMS.
  • Managing Learner Roles, curriculums, and training requirements in the Learning Management System ( Veeva Training ).
  • Supporting all onsite audits and regulatory or client inspections.
  • Contributing to other quality system improvement projects, including those related to the Veeva eQMS system .

What You'll Contribute

  • A Bachelor's degree or higher.
  • A minimum of 5-10 years of experience in a quality assurance role within the pharmaceutical industry.
  • Strong, hands-on experience with Electronic Document Management Systems (EDMS) and Learning Management Systems (LMS) , with a strong preference for Veeva QualityDocs and Veeva Training .
  • Excellent knowledge and understanding of applicable GxP regulations .
  • Demonstrated experience in identifying and resolving Good Documentation Practices (GDP) issues.
  • Familiarity with standard software such as the Microsoft Office Suite, DocuSign, Smartsheet, SharePoint, and Adobe Pro.
  • Exceptional attention to detail, strong technical writing skills, and the ability to work independently with minimal supervision.
  • Excellent organizational, interpersonal, and communication skills, with a strong sense of teamwork.
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    Document Control Manager • Alameda, CA, United States

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