GxP Associates

Technical Writer

GxP Associates
2 - 5 years
New Jersey, United States
Onsite
1 month ago

About the role

Job Summary
We are seeking a detail-oriented Technical Writer with 0–3 years of experience to create, maintain, and improve high-quality documentation for our products, systems, and processes. The ideal candidate will collaborate with cross-functional teams including Engineering, Quality, Product Management, and Regulatory to deliver clear, accurate, and user-friendly documentation. This role is well-suited for early-career professionals looking to build expertise in technical writing within fast-paced and regulated environments.
Key Responsibilities
  • Develop, edit, and maintain technical documentation including user manuals, SOPs, API documentation, and knowledge base articles
  • Translate complex technical concepts into clear, concise, and easy-to-understand content
  • Work closely with SMEs (Subject Matter Experts), developers, QA, and product teams to gather requirements and technical details
  • Create and manage documentation for software systems, tools, and workflows
  • Ensure all documentation complies with company standards, regulatory requirements, and industry best practices
  • Maintain version control and document lifecycle management in tools like SharePoint, Confluence, or document management systems
  • Support audit readiness by ensuring documentation accuracy and traceability
  • Continuously improve documentation processes and templates
  • Conduct document reviews and updates based on product releases and feedback

Required Qualifications
  • Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field
  • 0–3 years of experience as a Technical Writer in IT, software, or regulated industries (medical device, pharma, etc.)
  • Strong writing, editing, and proofreading skills
  • Experience with documentation tools such as MS Word, Confluence, MadCap Flare, or Adobe FrameMaker
  • Familiarity with version control systems (e.g., Git) and documentation workflows
  • Ability to understand technical concepts and communicate them effectively
  • Experience working in Agile or Scrum environments

Preferred Qualifications
  • Experience in regulated environments (ISO 13485, FDA, GxP)
  • Knowledge of QMS documentation (SOPs, CAPA, validation documents)
  • Exposure to API documentation tools (Swagger, Postman)
  • Basic understanding of HTML/CSS or Markdown
  • Experience with eQMS or PLM systems
See more jobs in New Jersey, United States