Documentation Specialist II

Position Title: Documentation Specialist

Work Location: Remote (Local to Irvine, CA)

Assignment Duration: 2 years (possible extension- performance based)

Work Schedule: Potential for schedule flexibility to cover EU sites to West Coast US time zones preferred.

Work Arrangement: Fully Remote with occasional onsite flexibility

Position Summary: Self-starter with attention to detail individual to handle product documentation requests from receipt to approved in document management system. Good communication skills in ensuring timelines are met.

Background & Context: Responsible for supporting documentation lifecycle and compliance within our organization.

Key Responsibilities:

• 
  

  Responsible for processing GxP documents in a document management system.

  
  
• 
  

  May be responsible for maintaining department's record archival and retention schedule in compliance with Corporate Record policies and procedures including GxP (GLP/GMP) requirements

  
  
• 
  

  May be responsible for supporting purchasing equipment, tracking and follow-up, working in a matrixed environment, managing shifting priorities.

  
  

Qualification & Experience:

• 
  

  Minimally high school equivalent and/or relevant experience

  
  
• 
  

  Self-starter with superior organizational and communication skills

  
  
• 
  

  Ability to effectively execute tasks with little oversight

  
  
• 
  

  Experience with Microsoft Office, DocXTool, OneVault, PowerApp preferred.

  
  
• 
  

  Demonstrated outcome implementing process workflow improvements including potential applications for AI/ML tools preferred.

  
  
• 
  

  Potential for schedule flexibility to cover EU sites to West Coast US time zones preferred.