IT Quality Specialist

Do you have a strong background developing SOPs aligned to FDA regulations in Life Sciences?

SQA is helping a biotech start-up stand up an IT Quality framework, part of which includes IT infrastructure SOPs. We are seeking an infrastructure/hardware-focused IT Quality Specialist with a strong background in technical writing of SOPs aligned to FDA regulations in the pharma industry.

Core responsibilities:

  • Support the creation of SOPs and work instructions
  • Report on issues/bottlenecks to leadership
  • Work with internal teams to obtain an in-depth understanding of the documentation requirements
  • Produce high-quality documentation that meets applicable standards and is appropriate for its intended audience
  • Write easy-to-understand SOPs, Forms and Guides
  • Create training materials to help support end-users’ understanding of SOPs


Critical Success Factors:

  • Strong background in technical writing of IT infrastructure SOPs aligned to FDA regulations in the pharma industry
  • Proven working experience in technical writing to define step by step documentation, including the creation of detailed process workflow diagrams and roles and responsibilities (RACI)
  • High-level understanding of IT infrastructure qualifications best practices
  • Ability to deliver high quality documentation within specified timelines
  • Ability to quickly grasp complex technical concepts and make them easily understandable in text, workflow diagrams and other visual representations
  • Excellent written and verbal interpersonal skills to interact with colleagues of all levels to effectively establish SOPs
  • Excellent communication style that assures clear and concise communications


Job ID: 1912-5826
SQA is an equal opportunity employer and supports workforce diversity.