In-Process Quality Engineer II

GUERBET • Raleigh, NC

72d

About The Position

At Guerbet, we build lasting relationships so that 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.

Requirements

• BS/BA degree in Science/Business preferred.
• Bachelor's degree in life sciences preferred.
• Minimum 6 years experience in a pharmaceutical QA/Mfg environment.
• ASQ inspection certification.
• Previous experience with statistical sampling plans.
• Previous experience in investigation root cause analysis and/or writing.
• Ability to work in a fast-paced environment.
• Ability to adjust work schedule to meet operations and customer demand.
• Must be able to wear appropriate personal protective equipment to ensure safe execution of job responsibilities.
• Skilled competency with computers, MS Office software required.
• Experience with pharmaceutical CAPA systems (e.g., Trackwise, Metric Stream, etc.) preferred.

Responsibilities

• Monitor compliance to meet or exceed site SOPs/cGMPs during production and packaging operations.
• Perform required QA inspections; i.e. Sample defect detection.
• Participate in internal audits, as requested.
• Provide primary daily support to the operations/packaging area, including tasks such as packaging line clearance verification, material segregation/containment, low product fill response, rework reconciliations/accountabilities, and documentation real-time review.
• Respond to exceptions within the operations/packaging areas, including initial exception impact assessment, product containment, bracketing, initial scope identification, and direction of immediate actions to take prior to resuming processing.
• Assist personnel in the generation of operations/packaging area related exceptions.
• Support minor exceptions and phase II manufacturing investigations.
• Attend daily operations staff communication meetings.
• Participate in Facilities meetings regarding operations Preventive Maintenance/Calibration/Work Order status and scheduling.
• Assist during area shutdown or maintenance projects, including punch list generation & verification, and area inspections pre/post activity.
• Perform weekly walkthroughs of the operations/packaging area and communicate observations to associated area management.
• Support the QA label release functions on an as-needed basis.

Benefits

• Continued personal development.
• Joining a global leader with recognized expertise in diagnostic and interventional imaging.
• Being part of a diverse team committed to improving quality of life for patients.

What This Job Offers

• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees