Sr. Infrastructure Scientist – QC Lab Systems

Role Summary

Sr. Infrastructure Scientist – QC Lab Systems will join the IPM Quality Control Organization and be part of the Lab Infrastructure Team. The role focuses on monitoring laboratory performance to maintain a state of control over analytical data and serving as a business SME for laboratory IT systems. It includes mentoring and educating other lab analysts on quality and lab systems, coordinating audits, and providing oversight for Management Review, laboratory metrics, and documentation.

The position supports deployment and upgrades of QC laboratory systems and contributes to continuous improvement of the Laboratory Quality System within Parenteral QC.

• Collect and report metrics related to quality processes.
• Act as business representative and SME for laboratory systems (Quality Docs, Trackwise, Empower, Darwin, Smart Lab, balance scorecard).
• Lead site deployment and upgrades of QC laboratory systems such as Darwin, Empower, Smart Lab, and Lab Vantage.
• Gather data and author management review documents for the Laboratory Quality system.
• Apply knowledge of quality principles, Laboratory Systems, and cGMPs toward the development and execution of local procedures, training courses (OJTs), and practices.
• Participate in identification and implementation of continuous improvement initiatives.
• Coordinate creation, revision, and archiving of laboratory documents.
• Manage and support audit and inspection activities for the QC laboratory.
• Provide technical oversight for development and management of laboratory methods and equipment; troubleshoot as required.
• Write protocols for non-routine testing or validation with appropriate guidance.
• Recognize deviations from procedures and initiate and participate in root cause investigations; share technical information and best practices within plant sites or groups.
• Own complex moderate/major deviations and mentor on change controls, analytical investigations, investigations for deviations, and activity planning as needed.
• Verify (SPV) analytical data of other analysts within the lab as requested.
• Comply with and implement safety standards.

• Required:
  
  Minimum 3 years of demonstrated GMP QC laboratory experience (analytical chemistry, microbiology, or biology).
• Required:
  
  Authorized to work in the United States on a full-time basis;
  Lilly will not sponsor work authorization or visas for this role.
• Preferred:
  Proficiency with computer systems including Microsoft Office products, LIMS, Lab Vantage, Smart Lab, Darwin, and MODA.
• Preferred:
  Knowledge and experience with aseptic techniques and EM / Micro QC Labs.
• Preferred:
  Ability to work in a lab environment including wearing PPE and safety equipment; demonstrate safe work practices.
• Preferred:
  Demonstrated strong oral and written communication and interpersonal skills.
• Preferred:
  Knowledge and experience with regulatory requirements.
• Preferred:
  Ability to influence and communicate to diverse groups on business or technical issues within the site and function.
• Preferred:
  Commitment to maintaining a safe work environment and supporting HSE goals.

• Bachelor’s degree in a science field related to the lab (e.g., chemistry, microbiology, biology).