Investigator

Guerbet; Raleigh (NC); On-site; USD 90,000 - 110,000; Full time

Job summary

Guerbet, a global leader in medical imaging, is hiring a Quality Investigator in Raleigh, NC. You will conduct site-related investigations, identify root causes, and recommend CAPAs with cross-functional teams to ensure regulatory compliance.

The role supports audits, data trending, SOP revisions, and continuous improvement initiatives to protect product and process integrity. Requires a 3–5 year background in a pharmaceutical or FDA-regulated setting and SAP proficiency.

Qualifications

• Bachelor’s degree in chemistry, Microbiology, Biology or Engineering is preferred.
• Other science-related degrees may be considered.
• Actual job experience may be used in lieu of degree.
• Minimum 3-5 years’ experience in a pharmaceutical, biological or other FDA-regulated industry setting is preferred.

Responsibilities

• Investigate and complete site related exceptions minor and major investigations or critical investigations with coaching based on demands of the department.
• Identify root cause and recommend appropriate CAPAs to address root cause.
• Perform Phase II OOS investigations.
• Supports external audits from regulatory agencies and customers (i.e., Document Runner, Documentation Pre-Review, Scribe, etc.).
• Assist in the department in trending of 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).
• Participate as a team member for site Kaizens or brainstorming initiatives to drive continuous improvement.
• Ability to perform SOP revisions as needed.
• Prepare GEMBA plans and perform walks to drive compliance and improve safety at the site.
• Ability to track the performance of assignments through to completion and meet with management on a weekly basis to report progress.

Skills

Root cause analysis

CAPA implementation

SOP revisions

SAP

Education

Bachelor's degree in chemistry

Science degree

Tools

MS Office

Job description

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 ARE LOOKING FOR

The Quality Investigator will be operating in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for.

The Quality Investigator is responsible for identifying and resolving quality issues by conducting detailed investigations and analyzing root causes. The Quality Inveseti work with cross-functional teams to implement corrective and preventive actions to ensure compliance with quality standards. This role supports continuous improvement to maintain product and process integrity.

YOUR ROLE

• Investigate and complete site related exceptions minor and major investigations or critical investigations with coaching based on demands of the department.
• Identify root cause and recommend appropriate CAPAs to address root cause.
• Perform Phase II OOS investigations.
• Supports external audits from regulatory agencies and customers (i.e., Document Runner, Documentation Pre-Review, Scribe, etc.).
• Assist in the department in trending of 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).
• Participate as a team member for site Kaizens or brainstorming initiatives to drive continuous improvement.
• Ability to perform SOP revisions as needed.
• Prepare GEMBA plans and perform walks to drive compliance and improve safety at the site.
• Ability to track the performance of assignments through to completion and meet with management on a weekly basis to report progress.
• The position will require independent decisions and personal judgment based on Company policies, SOPs, and GMPs.
• Proficiency in SAP.
• Performs other duties as assigned by management

YOUR BACKGROUND

Required Qualifications

• Bachelor’s degree in chemistry, Microbiology, Biology or Engineering is preferred
• Other science-related degrees may be considered
• Actual job experience may be used in lieu of degree
• Minimum 3-5 years’ experience in a pharmaceutical, biological or other FDA-regulated industry setting is preferred.

Preferred Qualifications

• Familiarity and skilled competency with computers.
• Familiarity and skilled competency with MS Office software (Word, Excel and Outlook) environment.

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 [e-mail] or you can also call this number+19843443717