GMP Technical Writing Specialist

Infotree Global Solutions; New Albany (OH); On-site; USD 65,000 - 90,000; Full time

Job summary

Infotree Global Solutions seeks a qualified technical writer to support the GMP manufacturing team. You will draft and revise SOPs, protocols, and training materials, ensuring documentation stays current in a regulated environment.

Responsibilities include creating and updating technical content, collaborating with multiple departments, and supporting deviations, CAPA, and change controls. Strong communication and Veeva experience are preferred.

Qualifications

• B.S. in Science or Engineering preferred.
• Experience in GMP pharma/biotech environment.
• Experience in technical writing within GMP context.
• Experience with device assembly and packaging of final product.
• Ability to translate technical content for manufacturing operators.
• Use of visuals (photos, diagrams, charts) to aid understanding.
• Experience supporting deviations, investigations, CAPA, and change controls.

Responsibilities

• Draft, revise, and maintain SOPs, protocols, technical reports, and training materials in GMP environment.
• Develop and update technical content including risk assessments and work instructions for manufacturing.
• Provide clerical support for document prep and data collection for technical records.
• Coordinate with manufacturing and cross-functional teams on documentation changes.
• Support change controls, deviations, CAPA investigations, and related records.
• Aim to reduce document turnaround times and keep schedules current.

Skills

GMP background

Excellent communication

Veeva experience

Education

B.S. in Science/Engineering

Job description

Infotree Global Solutions seeks a qualified technical writer to support the GMP manufacturing team. You will draft and revise SOPs, protocols, and training materials, ensuring documentation stays current in a regulated environment.

Responsibilities include creating and updating technical content, collaborating with multiple departments, and supporting deviations, CAPA, and change controls. Strong communication and Veeva experience are preferred.