Document Control Coordinator

Employer
Worldwide Clinical Trials
Location
Belgrade, RS
Salary
Competitive
Closing date
27 Sep 2020

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Discipline
Finance / Administration, Administration
Hours
Full Time
Contract Type
Permanent
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SUMMARY: The Document Control Coordinator, Process Management, is responsible for supporting the development and maintenance of GxP Quality Management Documents (QMDs) and Worldwide's Quality Management System (QMS). The individual performs document control activities, develops tools and ensures consistency and compliance with applicable standards. The individual assists Process Owners and functional collaborators with procedural document development in alignment with Worldwide's procedures for QMD lifecycle management.

RESPONSIBILITIES:
  • Serves as a champion of Worldwide's QMS by participating and encouraging a strong quality culture
  • Performs document control activities throughout the GxP QMD lifecycle, including but not limited to supporting the development, deployment, revision, retirement, archiving of QMDs
  • Supports tracking, and reporting of metrics for the document control and internal compliance functions
  • Contributes to preparation for the QMD Governance Committee (QMD-GC) meeting; may be assigned administrative duties regarding QMD-GC quorum management, minutes and archiving
  • Assists with the maintenance of the QMD Master Index, SOP Master Index, eQMS data entry, QMD deviation routing, tracking and archiving, and with other QMD management trackers and tools
  • Supports the process for external dissemination of Worldwide's QMDs
  • Collaborates with internal stakeholders to ensure compliance with the QMS and QMD lifecycle procedures
  • Executes individual goals for and supports team objectives of the QA document control organization
  • May participate in other departmental or cross-functional initiatives, as assigned
  • Perform other duties as assigned


OTHER SKILLS AND ABILITIES:
  • Communicates professionally, effectively, clearly and consistently, both verbally and in writing
  • Demonstrates a client-focused approach to work
  • Demonstrates critical thinking skills and ability to appropriately triage requests and concerns and escalate them
  • Demonstrates a detail-oriented work style, following requests and assignments to closure
  • Demonstrates a courteous, results-oriented commitment to build positive work relationships
  • Manages workload priorities and keeps supervision informed of challenges and availability
  • Works with a sense of urgency, recognizing and delivering time-sensitive deliverables by deadlines
  • Works with limited supervision and has a flexible approach to work assignments
  • Provides constructive input on processes and adapts to organizational changes

REQUIREMENTS:
  • Bachelor's degree in relevant discipline preferred; 3+ years of document control experience in a scientific, engineering or other technical field required
  • Ability to read, write and speak fluent English required
  • Experience managing procedural documents, such as SOPs, forms and templates, within last 2 years required
  • Strong Microsoft application skills, including in Excel, Outlook, PowerPoint and SharePoint required
  • Excellent Microsoft Word skills, including building and formatting forms, templates and related documents
  • Strong organizational and time management skills required
  • Experience with electronic Quality Management Systems (eQMS) an asset
  • Working knowledge of GxP regulations preferred
  • Understanding of the drug development process preferred
  • Domestic and international travel may be required (less than 10%)

#LI-KP1

Are You Seeking A Career With Purpose?

The time is right to join our growing team, consisting of 1,600 talented and dedicated employees from across the globe. We’re doing innovative and exceptional work each and every day. Our team is filled with purpose, as we support our sponsors in the discovery of cures and treatments for diseases affecting millions of people around the world.

If you’re looking to join an energetic and collaborative team that is valued and supported by company leadership, committed to operational excellence and open to creativity and innovation, Worldwide Clinical Trials could be the ideal place for you. We have exciting opportunities in clinical drug development, project management, corporate functions, sales, and more. Explore current openings and learn more about Worldwide’s culture below.

What We Believe

At Worldwide we operate under a shared mission, vision and set of cultural values. But these aren’t just words on a page. They are a daily inspiration and a shared commitment. Because we know that when we work towards a common goal and when we bring our best selves to the job every day we can climb mountains for our customers!

Contact Us
  • 2nd Floor
  • 172 Tottenham Court Road
  • W1T 7NS
  • GB
  • 0207 121 61 61
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