Writer: Quality Compliance (Remote)

FREELANCE OPPORTUNITY: Quality Compliance Writer

Target Start Date: Mid July

Location: Fully Remote

Length: Through End of Year (with potential extension)

Interview Process: 1-2 rounds

About:

Our client is a recognized leader in healthcare solutions, including nutrition, pharmacy admixture, and dialysis. As part of a global group the company is committed to safety, innovation, and knowledge sharing to help eliminate treatment errors and reduce costs. To accomplish this, they make sure all their SOPs, and quality agreements are properly communicated in written form.

Department Details:

• Reports to: Quality Assurance
• Team: Distributed across multiple U.S. locations
• Environment: Collaborative, compliance-focused, with structured documentation and processes

Ideal Candidate Experience:

• Industry Background: Pharmaceutical or Medical Device
• Role Fit: Quality Generalist or Quality Analyst with documentation experience in a regulatory environment
• Key Strengths: Writing, document control, and SOP development within FDA-regulated industries

Key Responsibilities:

• Write, revise, and maintain Quality Agreements (20-30 pages, template-based with provided data)
• Draft and update SOPs and Work Instructions
• Support Quality Compliance documentation: clearly defining roles/responsibilities between client and suppliers
• Investigate and document quality issues, helping implement preventive actions

Writing Expectation:

• Approximately 25-30% of documentation will require net-new (original) content creation
• Remaining work involves adapting or updating existing templates with project-specific data
• No AI writing tools permitted in the creation of official documentation

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