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Kelly Services Technical Writer

Petaluma, California
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Content Writer
#788030
Remote / WFH
Kelly Services

Job Description

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
Benefits
Pay: $60 - $70/hour DOE
Responsibilities
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
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
Job description
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.

10324968
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