Sr. Infrastructure Scientist – QC Lab Systems

Eli Lilly and Company • Us, IN

9d • Onsite

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Help deliver and shape the future of the lab and its constituent talent within the Parenteral Quality Control organization! The IPM QC Sr. Infrastructure Scientist (or Principal to Sr. Principal Scientist), will join the IPM Quality Control Organization and be part of the Lab Infrastructure Team. The candidate will be responsible for monitoring laboratory performance to ensure QC laboratory maintains a state of control regarding the generation and reporting of analytical data. Responsibilities include monitoring, execution, maintenance, and continuous improvement of the Laboratory Quality Systems (LQS) for Parenteral QC and serving as a business SME for laboratory IT systems. The candidate would be responsible for mentoring / educating other lab analysts on quality / lab systems, managing audit activities and for oversight for Management review, Laboratory metrics, and laboratory documentation. 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 such as Darwin, Empower, SmartLab®, LabVantage. Responsible for data gathering and authoring of management review document for the Laboratory Quality system. Apply knowledge of quality principles, Laboratory Systems, and cGMPs towards the development and execution of local procedures, training courses (OJTs), and practices. Participate in identification and implementation of Continuous Improvement initiatives. Coordinate creation / revision / archiving of laboratory documents. Manage and support Audit and Inspection activities for the QC laboratory. Responsible for technical oversight for development and management of laboratory methods and equipment. Troubleshoot equipment and methods as required. Write protocols for non-routine testing or validation with appropriate guidance. Recognizes when a deviation from procedures, etc. has occurred and initiates and participates in a Root Cause Investigation. Share technical information and best practice within plant sites or group. Owner of 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.

Requirements

• Bachelor (4-year college) degree in a science field related to the lab in which they are placed (e.g., chemistry for chem labs or micro or biology for micro or pharma lab)
• Minimum 3 years of demonstrated relevant experience in a GMP (analytical chemistry, microbiology, or biology) Quality Control lab
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

Nice To Haves

• Proficiency with computer systems including Microsoft Office products, LIMS, LabVantage, Smartlab, Darwin, and MODA preferred
• Knowledge and experience with Aseptic Techniques and EM / Micro QC Labs
• Ability to work in a lab environment including wearing appropriate PPE and other safety equipment and considerations
• Demonstrated strong oral and written communication and interpersonal interaction skills
• Knowledge and experience with Regulatory requirements
• Ability to influence and communicate to diverse groups on business, or technical issues within the site and function
• Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Corporate and Site Goals

Responsibilities

• monitoring laboratory performance to ensure QC laboratory maintains a state of control regarding the generation and reporting of analytical data
• monitoring, execution, maintenance, and continuous improvement of the Laboratory Quality Systems (LQS) for Parenteral QC and serving as a business SME for laboratory IT systems
• mentoring / educating other lab analysts on quality / lab systems
• managing audit activities and for oversight for Management review, Laboratory metrics, and laboratory documentation
• 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 such as Darwin, Empower, SmartLab®, LabVantage
• Responsible for data gathering and authoring of management review document for the Laboratory Quality system
• Apply knowledge of quality principles, Laboratory Systems, and cGMPs towards the development and execution of local procedures, training courses (OJTs), and practices
• Participate in identification and implementation of Continuous Improvement initiatives
• Coordinate creation / revision / archiving of laboratory documents
• Manage and support Audit and Inspection activities for the QC laboratory
• Responsible for technical oversight for development and management of laboratory methods and equipment
• Troubleshoot equipment and methods as required
• Write protocols for non-routine testing or validation with appropriate guidance
• Recognizes when a deviation from procedures, etc. has occurred and initiates and participates in a Root Cause Investigation
• Share technical information and best practice within plant sites or group
• Owner of 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

Benefits

• employees also will be eligible for a company bonus (depending, in part, on company and individual performance)
• Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level