Full-Time Senior Specialist, Quality Document Management & Training

The Senior Specialist, Quality Document Management & Training position is responsible and accountable for supporting and managing document control activities including the quality training program. This position will oversee all aspects of document management, including the creation, review, approval, distribution, and archival of quality management system documents and records.

• Document Management:
  • Manage and file all controlled GxP documentation in compliance with internal procedures and policies, as well as applicable regulatory requirements (FDA, ISO, CAP/CLIA).
  • Ensure document control requirements are met throughout the document lifecycle, including appropriate filing, archival and obsoletion.
  • Develop, implement, and maintain standardized processes, procedures, and tools for document management including document numbering, revision control, document distribution, and document review management.
  • Maintain records in accordance with company record retention policies.
• System Administration:
  • Serves as the eQMS administrator (e.g. maintain user access, assign user privileges/rights/passwords, manage and administer design changes to system workflows).
  • Contributes to continuous improvement and optimization of system workflows.
• Coordination of Training:
  • Assign new training, re-training, and cancellation of training.
  • Design, implement, and maintain training requirements and curriculums based on job functions.
  • Run training reports to monitor compliance and for client/audit requests.

• Bachelor’s degree or applicable experience in a Life Sciences discipline.
• 3+ years of experience in document control or quality systems, preferably in a medical device, IVD, Pharma, or CAP/CLIA clinical diagnostic lab or other regulated industry.
• Experience with MasterControl eQMS platform.
• Proficiency with Microsoft Office suite (Word, Excel) of products and similar tools.
• Strong collaboration across departments and within the organization.

What is the last date for applying to the job?

Which countries are accepted for this remote job?