In-Process Quality Engineer III

GUERBET • Raleigh, NC

71d

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

• Associates degree in Science/Business preferred or equivalent industry experience.
• Bachelor's degree in life sciences is a plus.
• Minimum 8-10 years of experience in a pharmaceutical QA/MFG environment is desired.
• ASQ inspection certification preferred; previous experience with statistical sampling plans (preferred).
• Previous experience in investigation root cause analysis and/or writing (preferred).
• Skilled competency with computers, MS Office software required.
• Experience with pharmaceutical CAPA and Documentation systems (e.g., Track wise, Metric Stream, etc.) is 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 simplified CAPAs and support 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 as needed, including punch list generation & verification, and area inspections pre/post activity.
• Perform weekly walkthroughs of the operations/packaging area and communicate any observations to associated area management.
• Support the QA label release functions on an as needed basis.
• Maintain active communication with customers to facilitate continuous process improvement.
• Identify, initiate, and implement process improvements within the Manufacturing and Quality areas.
• Oversee departmental projects to ensure associated timelines are met ahead of schedule.
• Pass visual acuity exam for production and identification of quality product purposes.

Benefits

• Continued personal development.
• Joining a global leader with recognized expertise in diagnostic and interventional imaging.
• Being part of a company that values diversity of talents.

What This Job Offers

• Job Type: Full-time
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Associate degree
• Number of Employees: 1,001-5,000 employees