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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