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Date:  Apr 18, 2024
Location: 

Raleigh, US

Job Type:  Long-term/regular

 Technical Writer II - (29019)

 

At Guerbet, we build lasting relationships so that we enable people to live better.  

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, as well as digital and AI solutions for diagnostic and interventional imaging. As a pioneer in contrast products for the last 95 years, we continuously innovate.   

  

Customer centricity, Cooperation, Audacity, Focus, and Responsibility are the values ​​that we share and practice.  

  

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on LinkedIn, Twitter, Instagram, and YouTube. 

 

WHAT WE'RE LOOKING FOR:

The Technical Writer is primarily responsible for conducting independent investigations, root cause determination and development of appropriate corrective/preventive actions for exceptions/OOSs occurring during manufacturing production at Guerbet. In addition, the incumbent will provide technical expertise to ensure that production activities are accomplished in a high quality, highly efficient and safe working manner. The incumbent serves as a subject matter expert in providing solutions to day-to-day production problems and will troubleshoot process related problems, write and revise SOPs and batch records, evaluate and provide input to internal and external audits. Incumbent is also required to maintain quality-minded, safe and ethical conduct while meeting production standards and schedules. This position is located in Raleigh, NC on first shift.

 

YOUR ROLE:

  • Write and finalize both simplified and standard CAPAs.

  • Leads and manages exception/OOS investigation in manufacturing areas. Utilize investigation tools such as risk assessment, 6Ms and KT analysis to identify investigation scope, true cause and product impact.

  • Coordinate procedure changes with the subject matter experts in the respective areas.

  • Work with the various departments in resolving current and potential compliance concerns.

  • Write and/or review Standard Operating Procedures to ensure they comply with current Good Manufacturing Practices.

  • Ensure safe work habits are employed and maintain a safe work environment.

  • Develop reports utilizing statistical tools identifying and trending KPIs.

  • Provide support and assist Operational Excellence Teams. 

 

YOUR BACKGROUND

Education required/ preferred:

Master’s degree in a Scientific, Engineering or Biotech field with 2-5 years’ experience in biopharmaceutical manufacturing processing in a GMP compliant environment

BA/BS Science, Biotech or Engineering Degree with 3-6 years’ experience in biopharmaceutical manufacturing processing in a GMP compliant environment.

Associate’s Degree/HS Diploma with 6-10 years’ experience in biopharmaceutical manufacturing processing in a GMP compliant environment.

 

Experience:

Conducting, writing and remediating investigations

Authoring and/or revising technical documents

Working cross-functionally, lead teams

 

Preferred Skills/Qualifications:

Knowledge of investigational tools such as risk assessment, 6Ms analysis. 

Exposure to conflict resolution and decision making.

Experience in root cause analysis.

Skills/Competencies:

PC proficient to include MS Office Suite.

Other Skills:

Good organizational skills and ability to coordinate multiple projects.

Must be able to work effectively in a team-based environment.

 

Skills/Competencies:

PC proficient to include MS Office Suite. Expertise in statistical programs and Access databases preferred.

Other Skills:

Good organizational skills and ability to coordinate multiple projects. Must be able to work effectively in a team-based environment.

 

 

 

EQUAL EMPLOYMENT OPPORTUNITY 

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 

  

WHY GUERBET?  

  • 4 weeks of PTO  

  • Insurance benefits start date of hire 

  • Competitive 4% 401K match + 2% profit sharing contribution  

  • Tuition reimbursement program for ongoing education 

  • Paid time off for select volunteer opportunities

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