Position Details
About this role
This role supports quality assurance and compliance activities within pharmaceutical technology, focusing on embedding regulatory standards into software development and validation processes.
Key Responsibilities
- Support compliance activities
- Translate regulatory requirements into technical specifications
- Maintain validation documentation
- Embed quality controls into pipelines
- Ensure inspection readiness
Technical Overview
Involves GxP, CSV, Part 11, Annex 11 compliance, traceability matrices, automation, and validation within healthcare IT environments.
Ideal Candidate
The ideal candidate is an experienced QA professional with 5+ years in healthcare or pharmaceutical industries, familiar with GxP, CSV, and regulatory standards. They should have strong skills in quality engineering, automation, and validation processes.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Certifications
Preferred
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of experience with GxP or CSV, No familiarity with regulatory standards, Unwilling to work in North Chicago, IL
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