Inspector I

Otsuka ICU Medical LLC; Austin (TX); On-site; USD 35,000 - 55,000; Full time

Job summary

Ein innovatives Unternehmen sucht einen engagierten Qualitätsinspektor, um die Produktionsprozesse zu überwachen und die Einhaltung von cGMP-Standards sicherzustellen. In dieser Rolle sind Sie verantwortlich für die Durchführung von Qualitätsprüfungen, die Dokumentation von Testergebnissen und die Zusammenarbeit mit internen und externen Kunden. Sie werden Teil eines Teams, das sich der Herstellung kritischer IV-Lösungen widmet, um sicherzustellen, dass Patienten die notwendigen Therapien ohne Unterbrechung erhalten. Wenn Sie detailorientiert sind und eine Leidenschaft für Qualitätssicherung haben, könnte dies die perfekte Gelegenheit für Sie sein.

Qualifications

• Mindestens ein Jahr Erfahrung als Produktionsmitarbeiter oder in der Qualitätssicherung.
• Fähigkeit, Daten in Computer einzugeben und mathematische Berechnungen durchzuführen.

Responsibilities

• Überwacht Produktionsprozesse auf Einhaltung der cGMP-Standards.
• Führt visuelle, funktionale und dimensionale Tests durch.

Skills

Qualitätskontrolle

Mathematische Berechnungen

Kommunikationsfähigkeiten

Detailorientierung

Mechanische Fähigkeiten

Education

High School Diploma

Tools

Laborausrüstung

Job description

Join to apply for the Inspector I role at Otsuka ICU Medical LLC

Position Summary

The Manufacturing Quality (MQ) Inspector’s responsibility will be to monitor production processes for compliance to cGMP standards. He/she will perform a variety of quality control checks to ensure appropriate utilization of equipment, commodities, product and procedures for the assigned production area. Conduct and document a variety of visual, functional and dimensional testing in support of commodity/product release – particularly in the bag fabrication, overwrap and packaging areas of production.

Essential Duties & Responsibilities

1. Inspects materials, batch record documents and final products during the production process or off line (APQR, re-inspection, batch records). Performs and records release functional and dimensional testing. Restarts automated equipment that stopped for quality issues.
2. Evaluates products for defects and recognizes unacceptable product. Makes decisions regarding product conformity and determines if MQ batch record criteria is met.
3. Performs testing on commodities and final product and determines acceptance according to specifications.
4. Collects file samples, stability testing samples, and laboratory samples in accordance with established procedures.
5. Inputs data (numerical/informational) into batch records, reports and electronic databases. Recognizes unacceptable product. Monitors production lines for irregularities and reports to area supervisor accordingly.
6. Works with both internal and external customers. Shares information and provides feedback on material, operational, and mechanical issues.
7. Performs mathematical calculations such as adding, subtracting, multiplying and dividing. Must have a working knowledge of mathematical applications.
8. Uses good problem solving and interpersonal skills for effective communication. Follows up on activities to ensure quality is maintained. Assists in area improvements, department changes and meetings.
9. Follows prescribed uniform and gowning requirements. Maintains a safe, orderly, clean work environment. Reports all accidents to the supervisor. Ensures all PPE is used, as required.
10. Adheres to cGMP guidelines, SOPs and plant policies. Assists in monitoring area for cGMP compliance.
11. Performs other related duties or special assignments as directed by supervisor.

Knowledge & Skills

• Must pass written and practical area requirements for area/certification.
• Ability to follow verbal and written instructions. Good communication skills in person and over the phone.
• Working knowledge of mathematical calculations, capable of working with fractions, decimals, and percentages. Ability to input data into a computer.
• Good mechanical skills to handle lab equipment.
• Ability to work independently and in a team. Dependable with good attendance.
• Detail-oriented with strong focus to detect irregularities.
• Adaptability to changing environments.
• Ability to maintain confidentiality.
• Ability to work independently with minimal supervision.

Minimum Qualifications, Education & Experience

• Must be at least 18 years old.
• High School Diploma required.
• Minimum one year of experience as a production operator or in quality. Back-up or specialist experience preferred.

Work Environment

• Work performed in a clean room environment.
• Ability to sit or stand for long periods.
• Occasional lifting up to 25 lbs.
• Travel less than 5%.

About Us

We manufacture critical IV solutions to ensure patients receive necessary therapies without disruption. Join us and contribute to healthcare innovation and reliability.

EEO Statement

Otsuka ICU Medical LLC is committed to diversity and equal opportunity. Reasonable accommodations available for individuals with disabilities. Contact us at [e-mail].