Technical Writer

Technical Writer (FDA/GMP Documentation)

Location: Petaluma, CA (100% Onsite)
Pay: $60 - $70/hour DOE
Duration: Contract to Hire based on performance

About the Role

Our client is seeking an experienced Technical Writer to develop FDA/GMP-compliant SOPs, work instructions, forms, and process documentation in support of a critical product launch. This is a hands-on role working closely with Sales and Operations to document business processes and build audit-ready quality documentation.

Responsibilities

• Develop SOPs, work instructions, forms, and controlled documentation.
• Document operational workflows from customer order through product shipment.
• Create documentation for complaint handling, product traceability, and quality processes.
• Work directly with subject matter experts to capture and document existing processes.
• Ensure documentation meets FDA and GMP requirements.
• Assist with training documentation as new procedures are implemented.

Minimum Qualifications

• 5+ years of experience writing SOPs and controlled documentation in an FDA-regulated environment.
• Experience supporting pharmaceutical, biotechnology, medical device, food manufacturing, or similar regulated industries.
• Strong knowledge of FDA regulations and Good Manufacturing Practices (GMP).
• Proven ability to independently develop clear, audit-ready documentation.
• Excellent communication, interviewing, and organizational skills.

Please note: General technical writing experience outside of FDA-regulated industries will not meet the requirements of this position.

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