Documentation Specialist

Company: HireTalent
Location: Greenville
Posted on: March 19, 2023

Job Description:

Job Title: Documentation Specialist
Job Location: Greenville, NC
Job Duration: 9 Months

Job Description:
This position provides administrative support for commercial batch record review, MasterControl documents, training modules and the electronic Quality Management System (eQMS).
Responsibilities

• 
  
• Perform review of executed commercial batch records to ensure quality and accuracy
  
• Partner with commercial supervisors and operators to handle corrections and/or discrepancies within executed commercial records
  
• Author and format SOPs, Impact Reviews and Change Controls within MasterControl; ensure documentation formatting is consistent, accurate and harmonized
  
• Ensure the documentation database is accurate and inputs conform to company standards
  
• Provide requested information during client and FDA audits
  
• Ensure all errors and corrections are resolved according to SOP requirements
  
• Enter data into applicable spreadsheets/database
  
• Participate and contribute to the continued implementation of electronic document software systems
  
  Education:
  
  
  • 
    
  • Bachelor s degree with at least 1 year of relevant experience
    
  • Associate degree with at least 3 years of relevant experience
    
  • High school diploma or equivalent with at least 4 years of relevant experience
    
  • Previous documentation control and management required
    
  • Proficient with Microsoft Office Word and Excel and Adobe Professional
    
  • Experience with database management software
    
    
    Physical Requirements:
    
    
    • 
      
    • Using a computer and sitting for long periods of time
      
    • Requires the capacity to handle and manipulate objects using hands and arms
      

Keywords: HireTalent, Greenville , Documentation Specialist, Other , Greenville, North Carolina