Distribution Center Quality Technician

At Guerbet, we build lasting relationships to enable people to live better. This is Our Purpose.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 100 years, we continuously innovate to improve the diagnosis, prognosis and quality of life of patients.

Customer centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team with nearly 3,000 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging.

Job Description

The Distribution Center Quality Technician is responsible for the timely inspection, review and / or audit of documentation, processes, and medical device shipments, with major impact on the site's ability to release compliant products from the Distribution Center.

Responsibilities

• Serve as the Primary Quality Auditor for Domestic and International Outbound Shipments to ensure compliance with local procedures and product requirements
• Serve as the Lead Auditor to ensure all special instructions are adhered to for Export Shipments for the Distribution Center's varying customers
• Serve as the primary contact for creating and sending requested Quality Documents on behalf of the Distribution Center
• Recommend and implement controls to ensure that quality standards are met
• Support the development and launch of standard operating procedures for the Distribution Center
• Support 3rd-party, regulatory and customer audits of the QMS, as well as requests for records
• Serve as lead investigator for all Quality Complaints or Nonconformances directed to the Cincinnati Distribution Center including tracking, reporting, and investigating quality errors by the DC Team
• Perform root cause analysis to determine underlying problems. Implement corrective and preventive actions to prevent recurrence of issues
• Work closely with Operations Engineering, Quality, Purchasing, Planning, and Production to achieve business objectives
• Actively help to maintain an efficient work environment by ensuring 6S Standards are met, driving quality and organization of the Distribution Center
• Perform duties as a back-up Quality Technician for operations when necessary.
• Support the Quality efforts of the Distribution Center Team and the Site Quality Department
• Provide quality updates to the Distribution Center Team at the daily tier meetings, including the Distribution Quality KPIs
• Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment.
• Responsible for ensuring DC compliance with GxPs and other regulatory requirements
• Responsible for participation in all Safety aspects of the plant
• Responsible for demonstrating initiative, self-direction, and ability to make decisions
• Requires a solid understanding of Good Documentation Practices (GDP) aligned with ALCOA+ principles, as well as the ability to effectively apply associated methods and tools in daily operations.
• Must understand and adhere to standard operating procedures (SOP's) in a pharmaceutical manufacturing environment and be able to apply Good Manufacturing Practices
• Understand and follow Good Manufacturing Practices (GMP)
• Requires successful completion of assigned training.

Requirements

Physical Requirements

Cognitive Requirements

J-18808-Ljbffr