Document Control and Training Specialist

Under guidance of the RAQA Director, the Document Control & Training Specialist maintains the company quality management system in compliance with federal and international regulations as well as ensures companywide training is up to date.

Essential Job Functions:

  • Manage release and control of updates to policies, procedures, instructions, etc.
  • Manage, maintain process and distribute controlled documents and records in compliance with applicable regulations and company procedures
  • Process all change orders for new and revised documents
  • Create or revise documents in support of system, product or process changes
  • Gather and prepare data for QA/RA meetings
  • Assist with internal/external audits, CAPA’s and other QA/RA tasks
  • Partners with managers and supervisors to ensure all training is completed timely and accurately
  • Responsible for maintaining all employee training records
  • Responsible for keeping KORU training matrix up to date
  • Responsible for new employee on-board training

Requirements:

  • High School degree or higher. At least 1-year experience in document control in the medical device or pharma industry preferred.
  • Strong background with Microsoft Office: Word, Excel, PowerPoint; certificate preferred.
  • Demonstrated ability with Microsoft Windows folder management
  • Ability to take direction and multi-task in a fast-paced manufacturing environment

Other Skills/Abilities:

  • Ability to work independently as well as in a team-oriented environment
  • Strong communications skills
  • Extremely detailed and organized
  • Track record that demonstrates personal initiative and process development

Job Type: Full-time

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Accepted formats: PDF, Word Doc

Accepted formats: PDF, Word Doc