Documentation Specialist

2 weeks ago

Whitby, Canada Thermo Fisher Scientific Full time
Job Summary

We are seeking a highly organized and detail-oriented individual to join our team as a Documentation Coordinator. In this role, you will be responsible for maintaining the controlled document library, ensuring compliance with regulatory requirements, and supporting audit preparations.

Key Responsibilities
  • Maintain accurate and up-to-date records of executed GMP documents, including batch records and validation reports.
  • Retrieve documents in a timely manner to support compliance audits and customer requests.
  • Enforce procedures governing document management and compliance requirements, including records retention policies.
  • Collaborate with cross-functional teams to ensure site requirements are met.
  • Manage the process for disposition of GMP documents, including shipment to clients or destruction of client and site documents.
  • Support compliance audits by retrieving and assembling documents as required.
  • Prepare documentation for off-site storage and maintain access to the controlled document library.
  • Respond to regulatory, customer, or internal requests for document information and general questions.
  • Facilitate periodic review of controlled documents in accordance with site procedure.
Requirements
  • High school diploma or equivalent required.
  • No previous experience required, but equivalent combinations of education, training, and relevant work experience may be considered.
  • Organized and detail-oriented with excellent communication and interpersonal skills.
  • Proficiency in Microsoft Office products, including Word, Excel, and PowerPoint.
Working Conditions

This role requires moderate physical effort and fatigue, with occasional climbing of ladders to reach upper shelves and regular movement of files, binders, and boxes of documentation to and from off-site storage.

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