Sr. Infrastructure Scientist – QC Lab Systems
Eli Lilly and Company
1 month ago
On-site
Indianapolis, IN
$65,250 - $169,400 USD yearly
Operations
Key Objectives / Deliverables
- Collect and report metrics related to quality process.
- Act as business representative and contact SME for laboratory systems (e.g., QualityDocs, Trackwise, Empower, Darwin, SmartLab, Balance scorecard).
- Lead site deployment and upgrades of QC laboratory systems (e.g., Darwin, Empower, SmartLab, LabVantage).
- Gather data and author management review documents for the Laboratory Quality system.
- Apply quality principles, Laboratory Systems, and cGMPs to develop and execute local procedures, OJTs, and practices.
- Identify and implement Continuous Improvement initiatives.
- Coordinate creation/revision/archiving of laboratory documents.
- Manage and support Audit and Inspection activities for the QC laboratory.
- Provide technical oversight for laboratory methods and equipment; troubleshoot as required.
- Write protocols for non-routine testing or validation.
- Initiate and participate in Root Cause Investigations for deviations; share technical information and best practices.
- Own complex moderate/major deviations; mentor on change controls and analytical investigations.
- Verify (SPV) analytical data of other analysts as requested.
- Comply with and implement safety standards.
Minimum Requirements
- Bachelor’s degree in a science field related to the lab (e.g., chemistry, microbiology/biology).
- Minimum 3 years of relevant experience in a GMP analytical chemistry, microbiology, or biology Quality Control lab.
- Full-time authorization to work in the United States (no visa sponsorship).
Additional Preferences
- Proficiency with Microsoft Office and LIMS/LabVantage/SmartLab/Darwin/MODA.
- Knowledge/experience with aseptic techniques and EM/Micro QC labs.
- Ability to work in a lab environment using appropriate PPE.
- Strong oral/written communication and interpersonal skills.
- Knowledge/experience with regulatory requirements.
- Ability to influence and communicate with diverse technical/business groups.
- Accountable for maintaining a safe work environment and supporting HSE goals.
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
- Collect and report metrics related to quality process.
- Act as business representative and contact SME for laboratory systems (e.g., QualityDocs, Trackwise, Empower, Darwin, SmartLab, Balance scorecard).
- Lead site deployment and upgrades of QC laboratory systems (e.g., Darwin, Empower, SmartLab, LabVantage).
- Gather data and author management review documents for the Laboratory Quality system.
- Apply quality principles, Laboratory Systems, and cGMPs to develop and execute local procedures, OJTs, and practices.
- Identify and implement Continuous Improvement initiatives.
- Coordinate creation/revision/archiving of laboratory documents.
- Manage and support Audit and Inspection activities for the QC laboratory.
- Provide technical oversight for laboratory methods and equipment; troubleshoot as required.
- Write protocols for non-routine testing or validation.
- Initiate and participate in Root Cause Investigations for deviations; share technical information and best practices.
- Own complex moderate/major deviations; mentor on change controls and analytical investigations.
- Verify (SPV) analytical data of other analysts as requested.
- Comply with and implement safety standards.
Minimum Requirements
- Bachelor’s degree in a science field related to the lab (e.g., chemistry, microbiology/biology).
- Minimum 3 years of relevant experience in a GMP analytical chemistry, microbiology, or biology Quality Control lab.
- Full-time authorization to work in the United States (no visa sponsorship).
Additional Preferences
- Proficiency with Microsoft Office and LIMS/LabVantage/SmartLab/Darwin/MODA.
- Knowledge/experience with aseptic techniques and EM/Micro QC labs.
- Ability to work in a lab environment using appropriate PPE.
- Strong oral/written communication and interpersonal skills.
- Knowledge/experience with regulatory requirements.
- Ability to influence and communicate with diverse technical/business groups.
- Accountable for maintaining a safe work environment and supporting HSE goals.
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation