Technical Writer

Kelly Science, Engineering, Technology & Telecom; Petaluma (CA); On-site; USD 83,000 - 96,000; Full time

Job summary

Kelly Science, Engineering, Technology & Telecom is partnering with an FDA-regulated manufacturer for a contract-to-hire Technical Writer role based in California. The position focuses on building audit-ready documentation for a major product launch, with new SOPs, work instructions, and controlled documents.

You'll document business processes from order to shipment, ensure compliance with FDA and GMP requirements, and collaborate with Sales and Operations to capture workflows.

Qualifications

• 5+ years of technical writing in an FDA-regulated industry.
• Experience writing SOPs and controlled documentation for regulated environments.
• Strong knowledge of FDA regulations and GMP.

Responsibilities

• Develop SOPs, work instructions, forms, and controlled documentation.
• Document business processes from customer order through product shipment.
• Create documentation for complaint handling, product traceability, and quality processes.
• Partner with Sales, Operations, and SMEs to capture existing workflows.
• Ensure all documentation meets FDA and GMP requirements.
• Assist with training documentation and process implementation.

Skills

Technical writing

FDA-regulated experience

SOPs & docs

Job description

$60 to $70/hour DOE

Contract to Hire based on performance

We're partnering with an innovative, FDA-regulated manufacturer that is preparing for a major product launch and is looking for an experienced Technical Writer to help build audit-ready documentation.

If you've written SOPs, work instructions, and controlled documentation in a regulated environment and enjoy turning complex processes into clear, compliant procedures, we'd love to hear from you!

What You'll Do

• Develop SOPs, work instructions, forms, and controlled documentation
• Document business processes from customer order through product shipment
• Create documentation for complaint handling, product traceability, and quality processes
• Partner with Sales, Operations, and other subject matter experts to capture existing workflows
• Ensure all documentation meets FDA and GMP requirements
• Assist with training documentation and process implementation

What We're Looking For

• 5+ years of technical writing experience within an FDA-regulated industry
• Experience writing SOPs and controlled documentation for pharmaceutical, biotechnology, medical device, food manufacturing, or similar regulated environments
• Strong knowledge of FDA regulations and Good Manufacturing Practices (GMP)
• Ability to independently create clear, audit-ready documentation with minimal supervision

Please note: This position requires prior experience writing controlled documentation in an FDA-regulated environment. General technical writing experience outside of regulated industries will not meet the requirements for this role.