Raleigh, US
In-Process Quality Engineer I (Manufacturing) M/F (28966)
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 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.
Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.
Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.
For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube
WHAT WE'RE LOOKING FOR:
Our Manufacturing (QA) I or In Process Quality Engineer I, 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 to 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. This position is a night shift, 9pm - 5am Monday through Friday, and located at the Raleigh, NC site.
YOUR FUNCTIONS:
1. Monitor compliance to meet or exceed site SOPs/cGMPs during production and packaging operations.
2. Perform required QA inspections. (i.e., Sample defect detection)
3. Perform the QA review and approval of executed Production batch records real-time (RTR).
4. Perform QA review for completed Sterilization records and associated documentation.
5. Ability to participate in internal audits, as requested.
6. Provide 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.
7. 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.
8. Assist personnel in the generation of Formulation, Filling and Packaging area related exceptions, as needed.
9. Support investigations for minor classified exceptions, as needed.
10. Team member of Facilities meetings regarding operations Preventive Maintenance/Calibration/Work Order status and scheduling, as designated.
11. Participate as a team member during area shutdown or maintenance projects, as needed.
12. Perform weekly walkthroughs of the operations/packaging area and communicate any observations to associated area management.
YOUR BACKGROUND:
Education required/ preferred: Associates degree in Science/Business preferred or equivalent industry experience. Bachelor’s degree in life sciences is a plus.
Experience: Minimum 2 years of experience in a pharmaceutical QA/MFG environment is desired.
Preferred Skills/Qualifications: ASQ inspection certification preferred; previous experience with statistical sampling plans (preferred); previous experience in investigation root cause analysis and/or writing (preferred).
Skills/Competencies: Ability to work in fast paced environment; Ability to adjust work schedule to meet operations and customer demand; Must be able to wear appropriate personal protective equipment to insure safe execution of job responsibilities.
Other Skills: Skilled competency with computers, MS Office software required.
Experience with pharmaceutical CAPA and Documentation systems (e.g., Trackwise, Metric Stream, etc.) is preferred.
The position routinely interfaces with various personnel from Formulation, Filling, Sterilization, Packaging, Laboratories, Facilities, Warehouse and QA.
Reason to join US
Much more than a Competitive salary,
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 2820 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 horizon.
We # Innovate # Cooperate # Care #Achieve at Guerbet.
Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.
Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to careers@guerbet.com or you can also call this number +19843443717