Assoc III, Validation
Baxter · Round Lake, IL
QualityFull-time$96k–$132kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Baxter seeks a Senior Quality Assurance professional to lead validation and data integrity programs at its Round Lake facility. The role involves overseeing complex validation projects, establishing governance frameworks, and ensuring cGMP and regulatory compliance across manufacturing operations.
What they're looking for
- Bachelor's degree in Engineering, Science, Computer Science, or related technical field
- 5+ years Quality Assurance, validation, or data integrity experience in pharmaceutical, biotech, or medical device manufacturing
- Strong knowledge of validation lifecycle, computerized systems, risk management, and regulatory requirements
- Experience reviewing validation documentation and assessing compliance risks in regulated environments
- Proven ability to lead cross-functional initiatives and communicate effectively at all organizational levels
- ASQ certification (CQE, CSQE, CQA) or equivalent preferred
- Experience supporting regulatory inspections and audit activities
What you'll be doing
- Provide QA leadership and oversight for complex validation projects with scientific and risk-based decision making
- Review and approve validation documentation including plans, protocols, reports, and revalidation activities
- Lead the site's Data Integrity Governance Program aligned with GAMP 5, 21 CFR Part 11, and ALCOA+ principles
- Partner with R&D, Manufacturing, and Engineering teams to support product introductions and manufacturing readiness
- Monitor program performance through metrics, investigate significant validation events, and support regulatory inspections
Privacy & handoff
This role links to Baxter's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.