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Software Quality Assurance (SQA) GxP / CSV

Company

Karwell Technologies

Location

Waukegan, Illinois, United States

Posted

May 16, 2026

Position Overview

Job Description:

The SQA is the quality authority for regulated software initiatives, ensuring that all changes, releases, and deployments comply with Client System Life Cycle (SLC) requirements, Computer System Validation (CSV) expectations, and global regulatory standards (e.g., 21 CFR Part 11, GAMP5).

The role balances compliance, delivery enablement, and risk-based decision-making, enabling predictable and audit ready releases.

Responsibilities:

"No release without validated evidence and approved SLC compliance.
SLC & Validation Governance:


  • Ensure mandatory SLC documentation is created, reviewed, and approved.

  • Act as the final quality gate before deployment.

  • CSV Oversight:

  • Ensure end to end traceability (requirements code test evidence).

  • Oversee deviations, ...

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