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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 Release Specialist

OUR NEED:​​​​​​

The In process Quality Engineer is a key member, and liasion within our operations. The position performs Quality Assurance (QA) review of batch records for filling, formulation and packaging for intermediate and finished products.  The position is required to review and evaluate compliance for executed batch records, reported chemistry and microbiology data and verification of exception event closures.  Product disposition is determined based on data and information collected and verified during the release process.
 

YOUR DUTIES:

  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. Compete verification documents for European markets and compile all documentation required for European production.
  6. Provide technical support and training for Quality and plant personnel.
  7. Demonstrate effective communication skills, both written and verbal, at all levels.
  8. 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.
  9.  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.
  10. Knowledge of manufacturing processes, utilities, and relevant statistical techniques (Six Sigma, Statistical Process Control (SPC), lean or equivalent).
  11. Readily identify and analyze problems and generate effective courses of action.
  12. Basic to intermediate proficiency in Microsoft Office, ERP systems and statistical programs (i.e., MiniTab, BPCS, MS Word).
  13. Maintain compliance with company SOPs and policies

     

YOUR BACKGROUND:

Education required/ preferred:

BS degree in a Science or related field preferred.

Experience:

Pharmaceutical Industry - minimum 5 years

Preferred Skills/Qualifications:

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

Skills/Competencies:

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

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

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.

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!