Document Control Specialist

• Maintain and manage the document control system for all quality and regulatory documents.
  
• Ensure all documents are correctly filed archived and retrievable.
  
• Ensure all documents meet regulatory requirements (e.g. FDA EMA GMP).
  
• Participate in internal and external audits providing necessary documentation and support.
  
• Develop templates for controlled documents.
  
• Revise and format documents for consistency across document types
  
• Coordinate the review and approval process for new and revised documents.
  
• Work with subject matter experts to ensure document accuracy and completeness.
  
• Train employees on document control processes and procedures.
  
• Ensure staff are aware of document changes and updates.
  
• Identify and implement improvements to the document control process.
  
• Stay updated on industry best practices and regulatory changes.
  
• Additional responsibilities as assigned.
  

Requirements

• Bachelor s degree in a relevant field.
  
• 310 years of experience in document control within the pharmaceutical industry.
  
• Familiarity with regulatory requirements and quality standards (e.g. FDA EMA GMP).
  
• Experience with Veeva is highly preferred.
  
• Strong attention to detail and organizational skills.
  
• Excellent written and verbal communication skills.
  
• Proficiency in document management software and MS Office Suite.
  
• Ability to work independently and as part of a team.
  
• Problemsolving skills and the ability to handle multiple tasks simultaneously.
  
• At PSC Biotech many of our projects and clients are located in various regions around the country. Therefore we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations cultures and work environments is essential as it allows our team members to collaborate effectively with clients and colleagues nationally.
  

Benefits