Supply Chain Quality Analyst

About the role

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 100 years, we continuously innovate to improve the diagnosis, prognosis and quality of life of patients. Customer Centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice on a daily basis. Working at Guerbet is not only being part of a multicultural team with nearly 3,000 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging.

Responsibilities

• Owns end-to-end batch release lifecycle: inbound raw materials, intermediates, and finished goods—reviewing batch records, Certificates of Analysis, and ensuring alignment with cGMP and GDP requirements.
• Coordinates cross-functionally (QC, QA, Manufacturing, Logistics) to resolve hold-ups, reconcile discrepancies, and communicate release status to stakeholders.
• Monitors batch release KPIs (e.g., release cycle time, documentation completeness, hold-to-release ratio); drives process improvements using CAPA methodology and procedural optimization.
• Facilitates GMP alignment at the warehouse–production boundary (label control, status segregation, quarantine, FEFO/traceability)
• Escalates nonconformances and deviations impacting release timelines, initiates investigations according to SOPs.
• Ensures strict compliance with data integrity (ALCOA+), maintaining electronic and paper records per 21 CFR Part 11, GDP, and internal Quality Systems.
• Reviews and updates SOPs/WIs related to batch release and material inbound quality release; supports training and competency assessments across teams.
• Performs ad-hoc quality checks (e.g., QC results, GMP documentation) and collaborates on material review board/QA disposition meetings.
• Ensures timely release of inbound raw material and excipient batches to prevent downstream manufacturing delays, coordinates laboratory escalation and deficiency resolution.
• Performs other duties as assigned by management.