350 Lilly Deutschland GmbH
Principal Scientist - Quality Control Chemical Testing Lab(m/w/x)
Vollzeitnur vor OrtManagement
Alzey
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35350 Lilly Deutschland GmbH
Scientist - Quality Control Stability Program and Supply Chain(m/w/x)
Alzey
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Maintaining cGMP and biosafety standards for batch release in a global pharma laboratory, ensuring data integrity. 3+ years regulated QC experience, stability program management, LIMS, and German/English skills required. Excellent company pension plan.
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
Berufserfahrung
- 3 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- LIMS
Benefits
Betriebliche Altersvorsorge
- Excellent company pension plan
Sonstige Vorteile
- Individual benefits
Karriere- und Weiterentwicklung
- Career development opportunities
Weiterbildungsangebote
- Access to professional development
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens 350 Lilly Deutschland GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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35350 Lilly Deutschland GmbH
Scientist - Quality Control Stability Program and Supply Chain(m/w/x)
Alzey
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Maintaining cGMP and biosafety standards for batch release in a global pharma laboratory, ensuring data integrity. 3+ years regulated QC experience, stability program management, LIMS, and German/English skills required. Excellent company pension plan.
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
Berufserfahrung
- 3 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- LIMS
Benefits
Betriebliche Altersvorsorge
- Excellent company pension plan
Sonstige Vorteile
- Individual benefits
Karriere- und Weiterentwicklung
- Career development opportunities
Weiterbildungsangebote
- Access to professional development
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens 350 Lilly Deutschland GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
350 Lilly Deutschland GmbH
Branche
Healthcare
Beschreibung
The company is a global healthcare leader dedicated to discovering and bringing life-changing medicines to those in need.
Noch nicht perfekt?
- 350 Lilly Deutschland GmbH
Principal Scientist - Quality Control Chemical Testing Lab(m/w/x)
Vollzeitnur vor OrtManagementAlzey - 350 Lilly Deutschland GmbH
Senior Manager Chemical Testing(m/w/x)
Vollzeitnur vor OrtSeniorAlzey - 350 Lilly Deutschland GmbH
Quality Control Expert Technician -- Incoming goods(m/w/x)
Vollzeitnur vor OrtJuniorAlzey - 350 Lilly Deutschland GmbH
Quality Assurance/Quality Control IT System Analyst(m/w/x)
Vollzeitnur vor OrtSeniorAlzey - 350 Lilly Deutschland GmbH
Responsible Scientist – QC Microbiology Lab(m/w/x)
Vollzeitnur vor OrtSeniorAlzey, Wiesbaden