Loading...
Share this Job

Guerbet is a leader in medical imaging worldwide, offering a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging, to improve the diagnosis and treatment of patients.

A pioneer since more than 90 years in the field of contrast media, Guerbet is continuously innovating with 9% of revenue dedicated to Research & Development and four centers in France, Israel and the United States.

Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €817 million in revenue in 2019 with a global workforce of over 2,800 employees.

Achieve, Cooperate, Care and Innovate are the values that Guerbet's employees share and practice every day. Working at Guerbet means playing a unique part in the future of medical imaging. Passionate about its business, the company strive day in, day out to combine performance, quality and sustainable development.

For more information about Guerbet, please go to www.guerbet.com  and follow Guerbet on Twitter @GuerbetGroup

 

Sr. Operations Quality Engineer

ABOUT US

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.

SUMMARY OF POSITION:

ESSENTIAL FUNCTIONS:

  • Participate in site internal audits within the entire plant, including routine clean room behavior audits.  This includes observation identification and resolution follow-up. 
  • Supportive position in the site execution of external audits from regulatory agencies (i.e. Document Runner, Documentation Pre-Review, etc.).
  • Assist in the department completion of trending and metrics (i.e. Cost of Poor Quality, Key Performance Indicators, Quality Management Reviews, & Data Trend Analysis).
  • Support data compilation for department requirements related to site Annual Product Reviews (APRs)
  • Investigate and complete site related complaints within a timely manner.
  • Investigate and complete site related exceptions (major and minor deviations) based on demands of the department.
  • Perform department-related simplified and standard CAPAs.
  • Possess some process technical knowledge and writing capabilities.
  • Ability to support Kaizens or brainstorming initiatives.
  • Ability to support site annual or non-routine GMP training.
  • Proactively assist with site regulatory compliance (US/EU/WHO/Brazilian/Korean standards).
  • Ability to perform SOP revisions as needed.
  • Ability to track the performance of assignments through to completion.
     

 

MINIMUM REQUIREMENTS

 

 

Education required/ preferred:

BS/BA degree in Life Sciences or Business preferred

Experience:

Minimum 4-5  years’ experience in a pharmaceutical setting preferred

Preferred Skills/Qualifications:

ASQ certified inspector/auditor preferred

Good documentation and organizational skills with eye for details

Skills/Competencies:

Ability to work in a fast-paced environment

Other Skills:

Meets Baseline Skills requirements; Familiarity and skilled competency with computers and MS Office software environment

 

 

WHY GUERBET?

  • Exempt-employee benefits start on start date, non-exempt benefits start a month after hire 
  • Competitive 4% 401K match + 2% profit sharing contribution
  • Tuition reimbursement program for ongoing education 
  • 4 weeks of PTO 
  • Opportunity to collaborate with colleagues around the world!