Quality Associate III
$96,000–$132,000 year
On-site · Round Lake, Illinois, United States
Job Summary
Quality Associate III (Quality Engineer) responsible for driving quality engineering initiatives and supporting regulatory compliance within a pharmaceutical manufacturing environment. Leads validation efforts and quality improvement projects, with a strong focus on enhancing and modernizing visual inspection programs for sterile products. Partners cross-functionally to implement process improvements and ensure compliance to quality standards. Plays a critical role in advancing product quality and supporting key regulatory and operational priorities. Key activities include leading daily departmental tasks, driving root-cause investigations for non-conformances, managing multiple process/product improvement projects (DOE, validations, new methodologies), data generation and reporting, maintaining audit readiness for FDA/ISO/Baxter quality requirements, and authoring and revising procedures. Requires a Bachelor’s degree in Science or Engineering and 5+ years of relevant experience, with strong technical writing, analytical, problem-solving, communication, and project management skills, plus familiarity with FDA regulations, GLP, and GMP. The role offers comprehensive Baxter benefits and a base salary range of $96,000–$132,000 annually.
Required Qualifications
- Bachelor’s degree in Science or Engineering required
- 5 or more years experience in IT, Engineering, Science or related field
- Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
- Strong technical writing skills
- Must be able to clearly document audit findings within audit reports
- Strong technical, analytical and problem solving skills
- Good interpersonal, communication, influencing, negotiation skills
- Understand scientific strategies and be able to invent new methods or new avenues of investigation
- Good interpersonal/communication/influencing/negation skills
- Good project management skills
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.