GMP Quality Engineer I: Compliance & Process Improvement

Otsuka ICU Medical LLC; Austin (TX); On-site; USD 65,000 - 85,000; Full time

Job summary

Otsuka ICU Medical LLC is seeking a Manufacturing Quality, Quality Engineer I to provide oversight and guidance in GMP-compliant manufacturing operations. The QE will coach personnel, identify quality issues, and perform safety inspections with recommendations for corrective actions.

The role emphasizes data-driven quality improvements and collaboration across manufacturing and QA teams, including support for satellite locations as assigned.

Qualifications

• Bachelor’s degree in Engineering or related field is required.
• 0-2 years of experience required.
• Previous pharma experience preferred.
• Experience in a clean room environment desirable.

Responsibilities

• Conduct evaluations and compliance walkthroughs to ensure GMP compliance.
• Perform real-time batch record reviews in assigned areas.
• Review equipment logbooks and evaluate adjustments for impact on product quality.
• Create, review, and revise procedures; assist with CAPA investigations.
• Perform data analysis and implement corrective/preventive actions to improve quality processes.
• Provide input for manufacturing quality decisions regarding events and deviations; implement corrective actions.

Skills

Team leadership

Strong communication

GMP knowledge

Quality systems understanding

Problem solving

Education

Bachelor’s degree in Engineering or related field

Job description

Otsuka ICU Medical LLC is seeking a Manufacturing Quality, Quality Engineer I to provide oversight and guidance in GMP-compliant manufacturing operations. The QE will coach personnel, identify quality issues, and perform safety inspections with recommendations for corrective actions.

The role emphasizes data-driven quality improvements and collaboration across manufacturing and QA teams, including support for satellite locations as assigned.