GMP Quality Supervisor - 3rd Shift

Otsuka ICU Medical LLC; Austin (TX); On-site; USD 85,000 - 120,000; Full time

Job summary

Otsuka ICU Medical LLC is seeking a Manufacturing Quality Supervisor to ensure GMP-compliant operations at our Austin facility. You will supervise quality engineers and inspectors, manage in-process monitoring, testing, and product release, and lead investigations and CAPAs when issues arise.

The role requires strong knowledge of GMP, quality systems, and effective cross-functional communication; 3rd shift is Wednesday-Friday and every other Saturday from 6:00pm to 6:00am, with travel minimal.

Qualifications

• Bachelor's degree required in Chemistry, Engineering, Biology, or Microbiology.
• Minimum 2 years in Quality, Manufacturing, Engineering, or R&D in pharma/related industries preferred.
• Strong knowledge of GMP and regulatory requirements essential.

Responsibilities

• Supervise quality engineers and inspectors in a manufacturing environment.
• Lead investigations and CAPA activities; prepare inspection and batch-review documents.
• Ensure SOP compliance and GMP adherence across production and QA activities.
• Collaborate with Operations, Materials, Engineering and other departments to resolve issues.

Skills

GMP knowledge

Quality investigations

Leadership

Analytical thinking

Education

Bachelor's degree in Chemistry, Engineering, Biology, or Microbiology

Tools

Statistical quality control

Job description

Otsuka ICU Medical LLC is seeking a Manufacturing Quality Supervisor to ensure GMP-compliant operations at our Austin facility. You will supervise quality engineers and inspectors, manage in-process monitoring, testing, and product release, and lead investigations and CAPAs when issues arise.

The role requires strong knowledge of GMP, quality systems, and effective cross-functional communication; 3rd shift is Wednesday-Friday and every other Saturday from 6:00pm to 6:00am, with travel minimal.