Technical Writer

Required Skills & Experience

• High School Diploma + 5+ years of related experience, OR Associate Degree + 3-4 years of related experience, OR Bachelor's Degree + 1-2 years of related experience
• Technical writing experience in a regulated environment
• Experience authoring or updating SOPs and controlled GMP documentation
• Strong written and verbal communication skills
• Ability to interview SMEs and translate technical information into clear documentation
• Strong attention to detail and proofreading skills
• Basic computer proficiency and document management system experience
• Must be able to gown for GMP manufacturing environments, including aseptic or sterile gowning when required

Nice to Have Skills & Experience

• Biopharmaceutical, pharmaceutical, or biotechnology manufacturing experience
• Experience with batch records (PBRs), GMP documentation, and quality systems
• Human Performance Tools experience
• Document control or quality documentation experience

Job Description

Insight Global is looking for a Technical Writer on site in Plainville, MA. This person will support GMP manufacturing operations by creating, updating, and maintaining controlled documentation. They will work closely with manufacturing SMEs and technical teams to ensure procedures are accurate, compliant, and easy to follow.

• Write, edit, and update SOPs, batch records, logbooks, job aids, and technical documents
• Partner with manufacturing SMEs to gather technical information and revise procedures
• Manage documentation workflows and document approvals
• Ensure documents meet GMP and quality standards
• Support controlled document lifecycle management from issuance through archival
• Maintain SOP libraries and manufacturing logbooks
• Train junior writers on documentation standards and best practices
• Participate in continuous improvement and compliance initiatives