Quality Assurance Technical Writer

Quality Assurance Technical Writer - Lebanon, IN (Onsite)

Industry: Pharmaceutical / GMP Manufacturing

We are seeking a detail-oriented Quality Assurance Technical Writer to support the Quality Compliance team during the startup phase of a new GMP manufacturing site in Lebanon, IN. This role will focus on developing, revising, and managing controlled quality documentation to ensure compliance with regulatory and company standards.

• Develop, edit, and maintain controlled GMP documents including SOPs, protocols, reports, and supporting tools
• Collaborate with subject matter experts (SMEs) across Quality, Manufacturing, Engineering, and Laboratory functions to ensure technical accuracy
• Support document management activities including revision control and lifecycle management
• Ensure documentation meets regulatory requirements and internal quality standards
• Maintain consistency, clarity, and readability for diverse audiences (HS diploma to PhD level)
• Assist with documentation efforts related to site startup and qualification activities
• Work within electronic document management systems (EDMS), preferably Veeva Quality Docs

• Bachelor’s degree required (Science or related field preferred)
• 3–5 years of pharmaceutical GMP technical writing experience
• Experience supporting startup or new facility environments is a plus
• Familiarity with utilities, manufacturing equipment, or laboratory systems preferred
• Experience with Veeva Quality Docs or similar EDMS strongly preferred
  
  Strong cross-functional collaboration skills
• Excellent written and verbal communication skills

• Experience in regulated pharmaceutical manufacturing environments
• Strong understanding of cGMP documentation practices
• Ability to manage multiple priorities in a fast-paced startup environment