Senior Manufacturing Quality Inspector

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

Position Summary

The Final Quality Assurance performs audit review on each batch record to ensure completeness and compliance before final release of products. This audit to assure the product has been manufactured in accordance with established quality standards. Final Quality Assurance is responsible to retain all batch records per retention procedure.

3rd shift: Sunday - Wednesday (6:00pm - 4:30am)

Essential Duties & 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
• Provides 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
• Ensures departmental compliance to all Federal, State, Local and Company regulatory requirements. These elements include FQA, EPA, FDA, OSHA, ISO, EEPC and Company policies relative to the manufacture of product, lot control requirements, documentation requirements, housekeeping, preventative maintenance, calibration, associate training and safety (equipment, associate)
• 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

Knowledge, Skills & Qualifications

Excellent Mathematical knowledge Good knowledge in records filing Good computer knowledge Ability to comprehend both verbal and written instructions

Education and Experience

High School Diploma or GED required Experience with medical devices/pharmaceutical GMPs preferred Minimum of 2 years in a FDA regulated manufacturing environment

Minimum Qualifications

Must be at least 18 years of age

Travel Requirements

Typically requires travel less than 5% of the time

Physical Requirements and Work Environment

While performing the duties of this job, the employee is regularly required to talk, hear and communicate on phone and through email. While performing the duties of this job, the employee is regularly required to sit which is mainly on the computer with some standing during shift Must be able to repetitively move and lift objects of up to 20 lbs

About Us

Innovation, Impact, and Purpose. Find Your Future Here. We manufacture the critical IV solutions providers count on to deliver consistent, reliable care. Each product we make helps ensure patients receive the therapies they need without disruption. When you work here, you become part of something bigger-a team dedicated to reliability and innovation. No matter the role, your work directly strengthens the healthcare supply chain and impacts patients nationwide. We offer opportunities for growth, collaboration, and meaningful contributions, all in pursuit of a mission that truly matters. Join us and help shape the future of IV solutions.

EEO Statement:

Otsuka ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status. If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at [e-mail]. We are committed to providing equal access and opportunities for all candidates.

Otsuka ICU Medical EEO Policy Statement

Know Your Rights: Workplace Discrimination is Illegal Poster

Otsuka ICU Medical CCPA Notice to Job Applicants