Company Overview
Fresenius Kabi, a global healthcare leader, is dedicated to enhancing and saving lives. With over 43,000 employees across more than 100 countries, the company offers a wide range of products, technologies, and services to support the care and treatment of critically and chronically ill patients.
Fresenius Kabi’s expansive product portfolio is focused on providing access to high-quality, lifesaving medicines and cutting-edge technologies. In the Biopharma sector, the company specializes in innovative biosimilars used in the treatment of autoimmune diseases and oncology. It holds a leading market position in Clinical Nutrition, offering a broad array of enteral and parenteral products that significantly improve patients’ nutritional health. In MedTech, Fresenius Kabi delivers essential medical devices, including infusion pumps, cell and gene therapy devices, and various disposables. Additionally, the company is the global leader in supplying blood collection bags and devices, supporting blood banks and healthcare facilities worldwide.
Primary Responsibilities:
-
Oversee and maintain the Investigative database for Incident, CAPA (Corrective and Preventive Action), and OOS (Out of Specification) investigations, ensuring accurate tracking and trending within KabiTrack, SAP, and external data sources.
-
Support validation projects by performing statistical analysis, trend analysis, or data collection related to fill weights. May also serve as a Study Director for qualifications, validations, or investigative studies.
-
Assist with site initiatives focused on achieving “right first time” and efficient batch release processes.
-
Evaluate Alert and Action Levels for visual inspections, complaints, and fill yields by conducting statistical analysis of production and quality data, and update or maintain relevant standard operating procedures (SOPs).
-
Utilize appropriate statistical methodologies for both descriptive and inferential analysis as requested by management, supporting investigations, CAPAs, validations, or Tech Transfer projects.
-
Collect and analyze facility event and CAPA reports, preparing weekly trend analysis reports for site metrics to help maintain the facility’s scorecard.
-
Create or revise corporate and site SOPs using Documentum.
-
Perform GAP analysis to ensure key areas of manufacturing and quality compliance are evaluated thoroughly.
-
Execute additional duties as directed by management.
Preferred Skills:
-
Strong proficiency in Microsoft Excel.
-
Experience with Minitab, Letter R, VBA coding, and Python (not required).
-
Six Sigma Green Belt certification preferred.
-
In-depth understanding of quality control processes in a laboratory environment.
-
Ability to collaborate effectively in a team while managing multiple projects simultaneously.
-
Excellent written and verbal communication skills for reporting results.
Requirements:
-
Bachelor’s degree in a related technical field with a focus on statistical analysis.
-
3-5 years of relevant work experience in a technical field focused on statistical analysis.