Investigator

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 Investigator works 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. 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 View email address on click.appcast.io or you can also call this number +1 984 344 3717. #J-18808-Ljbffr Guerbet