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Document ControllerGlobalchannelmanagement • Indianapolis, Indiana, USA
Document Controller

Document Controller

Globalchannelmanagement • Indianapolis, Indiana, USA
Hace 6 días
Salario
40,00 US$ por hora
Tipo de contrato
  • A tiempo completo
Descripción del trabajo

Document Controller needs f 4 years of experience in document control within a regulated (GxP) pharmaceutical or biotechnology environment

Document Controller requires:

  • Demonstrated hands-on experience managing controlled documents using Veeva QualityDocs (required)
  • Experience supporting inspections audits periodic reviews and documentation gap assessments Educational Requirements:
  • Bachelors degree or equivalent experience
  • Strong written and verbal communication skills
  • Detailed knowledge of Quality policies procedures and document control principles
  • Strong attention to detail organizational skills and ability to manage multiple priorities
  • Proven ability to work independently and influence across functions

Document Controller mist duties:

  • Owns and manages the end-to-end document control lifecycle for QA documentation including creation revision review approval issuance archiving and retirement in compliance with GQS and LQS requirements
  • Provides subject matter expertise on document control standards processes and best practices to QA and cross-functional partners
  • Reviews QA documentation for accuracy completeness formatting and compliance with quality standards and regulatory expectations
  • Leads and supports periodic review and gap assessment activities identifying documentation gaps risks and remediation needs
  • Coordinates and facilitates document routing through electronic or manual review and approval workflows ensuring timely execution
  • Maintains controlled document repositories to ensure documents are current traceable and readily accessible for operations and inspections
  • Tracks monitors and reports documentation status metrics and deliverables to QA Operations leadership
  • Supports inspection readiness activities by ensuring controlled documents are inspection-ready and aligned with site practices
  • Partners with QA and operational stakeholders to support documentation strategies for new processes changes and remediation efforts
  • Identifies opportunities to improve document control efficiency consistency and compliance


Employment Type : Full Time
Experience: years
Vacancy: 1
Hourly Salary Salary: 40 - 41
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Document Controller • Indianapolis, Indiana, USA

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