In-Process Quality Engineer III (Raleigh, US) presso Welcome to Guerbet | Guerbet

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. 

WHAT WE ARE LOOKING FOR

The In-Process Quality Engineer is responsible for monitoring formulation, filling, sterilization, and packaging operations for compliance to site SOPs and cGMP including timely review of cGMP documentation at designated, critical, process points. Monitors the production/packaging areas for compliance. Inspects product samples to ensure compliance with Guerbet requirements. Participates in containment, recovery, issue escalation process, and corrective actions involving atypical quality events. Supports team members to ensure all sampling is accomplished in a timely manner and any defect related issues are addressed. Supports site and departmental initiatives. IPQE III Associates are expected to function with a moderate level of oversite from the department manager.   

YOUR ROLE

• Monitor compliance to meet or exceed site SOPs/cGMPs during production and packaging operations. 
• Perform required QA inspections; i.e Sample defect detection. 
• Ability to participate in internal audits, as requested. 
• Provide primary daily support to the operations/packaging area, up to and including tasks such as packaging line clearance verification, material segregation/containment, low product fill response, rework reconciliations/accountabilities, and documentation real time review. 
• Primary QA event response personnel that will respond to exceptions within the operations/packaging areas, having functions of 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. 
• Have the ability to support minor exceptions and simplified CAPAs and support phase II manufacturing investigations.  
• Attend daily operations staff communication meetings. 
• Team member of Facilities meetings regarding operations Preventive Maintenance/Calibration/Work Order status and scheduling. 
• Team member during area shutdown or maintenance projects as needed.  Assisting in punch list generation & verification, as well as area inspections pre/post activity. 
• Perform weekly walkthroughs of the operations/packaging area and communicate any observations to associated area management.   
• Ability to 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. 
• Ability to pass visual acuity exam for production and identification of quality product purposes. 

Department Specific/Non-Essential Functions:

• Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. 
• Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. 
• Report all safety and/or environmental incidents to management immediately.
• Other duties as assigned with or without accommodation.

YOUR BACKGROUND

• 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.

We offer continued personal development. When you join Guerbet, you: 

• Are choosing a global leader with recognized expertise in diagnostic and interventional imaging, 
• Are joining our 3000 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,
• Are joining a company where we value diversity of talents coming from various horizons. 

Do you want to help improve patients’ lives with us? 
We look forward to meeting you and continuing our story together! 

We # Innovate # Cooperate # Care #Achieve at Guerbet.  

Guerbet is a signatory of the Diversity Charter. 
We believe diversity is a source of strength, and all our positions are open to everyone. 

Guerbet is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant based on race, color, religion, national origin, sex, age, disability, veteran or military status, genetic information, pregnancy or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identity, and maintain employment statistics on applicants.    

Applicants may be entitled to reasonable accommodation due to disability, pregnancy or related medical condition, or a sincerely held religious belief. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing an undue hardship on Guerbet. Please inform the company’s personnel representative if you need assistance completing this application or to otherwise participate in the application process.    

Guerbet will not discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.