GMP Technical Writer

Job Title: Technical Writer

Location: Onsite – Atlanta, GA (W2 Only)

Position Summary

We are seeking an experienced Technical Writer to support documentation and change control activities in a regulated/GMP environment. The ideal candidate will have strong expertise in creating, reviewing, and managing complex product documentation and SOPs, along with hands-on experience supporting Change Control processes.

Key Responsibilities

• Create, edit, review, and maintain technical documentation including SOPs, work instructions, and product documentation.
• Support Change Control (CR) documentation from initiation through closure, ensuring accuracy, compliance, and timely execution.
• Manage multiple change requests simultaneously while meeting project timelines and quality standards.
• Collaborate with engineering, quality, manufacturing, and validation teams to gather technical information and translate it into clear, compliant documentation.
• Ensure all documentation adheres to GMP and internal quality system requirements.
• Plan, organize, and execute documentation work plans, including revisions and continuous improvements.
• Participate in document reviews, audits, and inspections as needed.

Required Qualifications

• 5 years of experience in technical writing.
• Strong ability to read, write, and interpret complex technical and product documentation.
• Excellent attention to detail and ability to understand high-level technical concepts.
• Experience working in a regulated and/or GMP environment.
• Hands-on experience with Change Control (CR) documentation.
• Proven ability to manage multiple CRs and competing priorities effectively.

Preferred Qualifications

• Solid understanding of GMP concepts and core quality system processes.
• Familiarity with process improvement methodologies such as LEAN.
• Experience supporting cross-functional teams in manufacturing or life sciences environments.
• Strong planning, organization, and execution skills for documentation projects.
• Demonstrated change management and stakeholder coordination abilities.