Onsite GMP Technical Writer - SOPs & Change Control Expert

Planet Pharma; Clayton (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

Planet Pharma onsite in Clayton, NC seeks a pharmaceutical technical writer to create, revise, and manage GMP documentation supporting manufacturing operations, process engineering, facilities, training, and quality systems.

This role goes beyond editing; you will translate complex production activities into clear written instructions, author SOPs, work instructions, and controlled documents, and work with SMEs to ensure accuracy and compliance.

Qualifications

• Pharmaceutical manufacturing experience preferred.
• Experience supporting GMP-regulated documentation.
• Experience authoring and managing SOPs, Work Instructions, and quality documents.

Responsibilities

• Create, revise, and manage operational documentation for pharmaceutical manufacturing.
• Translate complex manufacturing activities into clear written instructions.
• Review documents for compliance, readability, and accuracy.
• Manage document revisions through approval workflows.
• Collaborate with SMEs, QA, and Learning & Development.
• Coach document owners on writing standards.

Skills

Technical writing

SOPs

Documentation management

Change control systems

SME collaboration

Editing not enough

Job description

Planet Pharma onsite in Clayton, NC seeks a pharmaceutical technical writer to create, revise, and manage GMP documentation supporting manufacturing operations, process engineering, facilities, training, and quality systems.

This role goes beyond editing; you will translate complex production activities into clear written instructions, author SOPs, work instructions, and controlled documents, and work with SMEs to ensure accuracy and compliance.