350 Lilly Deutschland GmbH
Principal Scientist - Quality Control Chemical Testing Lab(m/w/x)
Full-timeOn-siteManagement
Alzey
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35350 Lilly Deutschland GmbH
Scientist - Quality Control Stability Program and Supply Chain(m/w/x)
Alzey
Full-timeOn-siteExperienced
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 3 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- LIMS
Benefits
Retirement Plans
- Excellent company pension plan
Other Benefits
- Individual benefits
Career Advancement
- Career development opportunities
Learning & Development
- Access to professional development
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 350 Lilly Deutschland GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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- 350 Lilly Deutschland GmbH
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Full-timeOn-siteSeniorAlzey, Wiesbaden
35350 Lilly Deutschland GmbH
Scientist - Quality Control Stability Program and Supply Chain(m/w/x)
Alzey
Full-timeOn-siteExperienced
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 3 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- LIMS
Benefits
Retirement Plans
- Excellent company pension plan
Other Benefits
- Individual benefits
Career Advancement
- Career development opportunities
Learning & Development
- Access to professional development
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 350 Lilly Deutschland GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
350 Lilly Deutschland GmbH
Industry
Healthcare
Description
The company is a global healthcare leader dedicated to discovering and bringing life-changing medicines to those in need.
Not a perfect match?
- 350 Lilly Deutschland GmbH
Principal Scientist - Quality Control Chemical Testing Lab(m/w/x)
Full-timeOn-siteManagementAlzey - 350 Lilly Deutschland GmbH
Senior Manager Chemical Testing(m/w/x)
Full-timeOn-siteSeniorAlzey - 350 Lilly Deutschland GmbH
Quality Control Expert Technician -- Incoming goods(m/w/x)
Full-timeOn-siteJuniorAlzey - 350 Lilly Deutschland GmbH
Quality Assurance/Quality Control IT System Analyst(m/w/x)
Full-timeOn-siteSeniorAlzey - 350 Lilly Deutschland GmbH
Responsible Scientist – QC Microbiology Lab(m/w/x)
Full-timeOn-siteSeniorAlzey, Wiesbaden