Beschreibung

In this role, you will ensure the timely and compliant management of quality control processes, overseeing sample handling and collaborating on stability studies. Your daily responsibilities will include data review, trend analysis, and working with cross-functional teams to maintain high standards in product stability.

Anforderungen

• •Bachelor’s or associate’s degree in chemistry, biology, or other science disciplines
• •Minimum of 3 years of regulated industry experience in QC
• •Hands-on experience in stability program management
• •Experience in working with LIMS
• •Written and oral skills in German and English
• •Participation in regulatory inspections as a SME
• •Management experience on third-party laboratories

Aufgaben

• •Ensure timely completion of work to support batch release and site priorities
• •Adhere to Environmental Health and Safety (EHS) requirements and laboratory safety procedures
• •Maintain cleanliness and contamination control in line with cGMPs and biosafety guidelines
• •Execute activities in compliance with standard operating procedures (SOPs) and regulatory guidelines
• •Maintain data integrity standards and ALCOA+ principles during activities
• •Perform data review to ensure accuracy and compliance
• •Identify and escalate atypical results and potential deviations
• •Participate in root cause analysis for laboratory investigations
• •Implement corrective and preventive actions as required
• •Communicate opportunities for continuous improvement
• •Participate in cross-functional teams as needed
• •Maintain training competencies and execute work only where qualified
• •Support audit and inspection readiness through compliant activities
• •Oversee sample and retains management processes
• •Review sample requests to determine priority levels
• •Proactively resolve discrepancies with sample submitters or manufacturing contacts
• •Participate in QC scheduling meetings to provide updates on sample management
• •Collaborate with global teams to plan stability studies
• •Coordinate collection, receipt, and storage of stability samples
• •Ensure timely delivery of stability samples to QC or third-party labs
• •Track stability testing progress and address delays
• •Oversee stability data and conduct time point results reviews
• •Analyze stability trends and provide input on shelf-life
• •Compile stability summary reports as needed
• •Perform final reviews of stability studies and prepare reports
• •Manage third-party labs involved in the stability program

Tools & Technologien

Benefits