QA Documentation Specialist

QA Documentation Specialist

Position Overview

Our client is seeking a QA Documentation Specialist to support the development, revision, and review of GMP manufacturing documentation. The ideal candidate will have pharmaceutical or life-sciences experience and a strong understanding of how to create and assemble clear, compliant batch records.

Key Responsibilities

• Create, revise, format, and review master batch records and related manufacturing documents.
  
• Work with Quality, Manufacturing, and technical subject-matter experts to collect required information.
  
• Ensure documents comply with GMP, good documentation practices, and site procedures.
  
• Manage document revisions, approvals, and version control.
  
• Identify documentation gaps and support corrections.
  

Qualifications

• Experience developing or reviewing batch records in a pharmaceutical, biotech, or life-sciences environment.
  
• Working knowledge of GMP and good documentation practices.
  
• Strong technical writing, editing, formatting, and organizational skills.
  
• Experience with document-control or electronic quality-management systems is preferred.