Senior Quality Inspector - Final Batch Audits (3rd Shift)

Otsuka ICU Medical LLC; Austin (TX); On-site; USD 60,000 - 80,000; Full time

Job summary

Otsuka ICU Medical LLC is seeking a Final Quality Assurance professional for the 3rd shift (Sun–Wed, 6:00pm–4:30am) in Austin, TX. The role conducts batch-record audits to ensure completeness and regulatory compliance before final product release.

Responsibilities include releasing products via Oracle/iFactory, updating device serial info, and providing QA support to detect quality risks, ensuring adherence to FDA, ISO, and company policies.

Qualifications

• High School Diploma or GED required.
• Minimum 2 years in a FDA regulated manufacturing environment.
• Experience with medical devices/pharmaceutical GMPs preferred.
• Ability to work 3rd shift (Sunday–Wednesday, 6:00pm–4:30am).

Responsibilities

• Perform audits on batch records to ensure completion and compliance.
• Execute final product release via Oracle system.
• Update serial device information in iFactory/Oracle.
• Provide Manufacturing/MQA support to detect quality risks.
• Ensure records are documented per procedures.

Skills

Auditing

Quality systems

Problem solving

Communication

Education

High School Diploma or GED

Tools

Oracle

iFactory

Job description

Otsuka ICU Medical LLC is seeking a Final Quality Assurance professional for the 3rd shift (Sun–Wed, 6:00pm–4:30am) in Austin, TX. The role conducts batch-record audits to ensure completeness and regulatory compliance before final product release.

Responsibilities include releasing products via Oracle/iFactory, updating device serial info, and providing QA support to detect quality risks, ensuring adherence to FDA, ISO, and company policies.