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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

 

Quality Engineer - 2nd Shift

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.
 

ESSENTIAL FUNCTIONS

 

  1. Review executed batch records, and associated documentation for compliance with cGMPs and consistency with other Guerbet policies and procedures.
  2. Responsible for final audit and review of product documentation for Finished Goods and Returned Goods to conform to plant procedures and industry practices.
  3. Coordinate the lot release schedule with Operations and Warehouse management to ensure efficient and on-time release of product batches.
  4. Review and evaluate Quality Control (QC) data for release and approval of batch records and drug product.
  5. Perform product disposition and control functions in BPCS.
  6. Compete verification documents for European markets and compile all documentation required for European production.
  7. Provide technical support and training for Quality and plant personnel.
  8. Track and trend compliance issues and provide feedback to area management.
  9. Demonstrate effective communication skills, both written and verbal, at all levels.
  10. Mentor and advise junior team members from various groups within manufacturing and packaging concerning regarding quality-related issues and compliance with regulatory requirements and company policies.
  11.  Perform multiple tasks and effectively manage conflict.
  12.  Work in both individually and within the team to obtain results, along with the ability to organize and adjust to shifting priorities and production schedule changes.
  13. Knowledge of manufacturing processes, utilities, and relevant statistical techniques (Six Sigma, Statistical Process Control (SPC), lean or equivalent).
  14. Readily identify and analyze problems and generate effective courses of action.
  15. Basic to intermediate proficiency in Microsoft Office, ERP systems and statistical programs (i.e., MiniTab, BPCS, MS Word).
  16. Understanding of continuous improvement methodologies including lean, six sigma and validation.
  17. Maintain compliance with company SOPs and policies

     

MINIMUM REQUIREMENTS

Education required/ preferred:

BS degree in a Science or related field preferred.

 

Experience:

Pharmaceutical Industry - minimum 5 years

Auditing and reviewing documentation

Working knowledge of Microsoft Office

 

Preferred Skills/Qualifications:

ASQ Certified Auditor; problem solving, decision making and supervisory skills

 

Skills/Competencies:

Thorough knowledge and understanding regulations or guidelines of cGMP’s, GLP, ICH, USP, FDA and pharmaceutical industry guidelines.

Proven organizational, presentation, meeting facilitation and technical writing skills.

Familiarity with manufacturing: filling, formulation, packaging areas and laboratory testing of chemistry and microbiology

Verify accurate transcription of raw data into reports. Audit above testing for compliance to all applicable SOPs and regulatory requirements.

Discuss issues with manufacturing/ packaging and laboratory staff as discovered during final report auditing, laboratory walkthroughs, or other internal audits.

Auditing background and the ability to work/contribute in a team based environment as a lead and a participant, exceptional interpersonal skills, and adept problem solving skills.

Familiarity with the Exception and CAPA processes.

Adherence to SOP’s, policies and procedures associated with Liebel-Flarsheim (Raleigh) site and Guerbet.

Knowledge of manufacturing processes, utilities, and relevant statistical techniques (Six Sigma, Statistical Process Control (SPC), lean or equivalent).

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!