Senior Manufacturing Quality Inspector - 3rd Shift

Otsuka ICU Medical; Austin (TX); On-site; USD 65,000 - 90,000; Full time

Job summary

Otsuka ICU Medical in Austin, TX is seeking a Final Quality Assurance professional to audit batch records for completeness and compliance before final product release. This role ensures products are manufactured to GMP standards and that records are retained per procedures.

The position requires a High School Diploma or GED, at least 2 years in FDA-regulated manufacturing, and GMP experience with medical devices/pharmaceuticals.

Qualifications

• High School Diploma or GED required.
• Minimum of 2 years in FDA regulated manufacturing.
• Experience with medical devices/pharmaceutical GMPs preferred.
• Must be at least 18 years of age.

Responsibilities

• Perform audits on each batch record to ensure completion and compliance (in hard copy or electronic version).
• Execute final product release via iFactory / Oracle system.
• Access to Oracle Installed Base to update serial device information.
• Provide Manufacturing / MQA support to detect quality risks.
• Verify that the records documented are within the corresponding procedures.
• Demonstrate leadership, problem solving skills and technical knowledge with solid communication skills, attitude, dedication and commitment.
• Ensure departmental compliance to all Federal, State, Local and Company regulatory requirements (FQA, EPA, FDA, OSHA, ISO, EEPC and Company policies).
• File and retain batch records in controlled area per retention procedure.
• Ability to troubleshoot and work in a team environment.
• Other activities related to the position.

Skills

Mathematics

Records filing

Computer literacy

Communication skills

Education

High School Diploma or GED

Job description

Otsuka ICU Medical in Austin, TX is seeking a Final Quality Assurance professional to audit batch records for completeness and compliance before final product release. This role ensures products are manufactured to GMP standards and that records are retained per procedures.

The position requires a High School Diploma or GED, at least 2 years in FDA-regulated manufacturing, and GMP experience with medical devices/pharmaceuticals.