Quality Control Laboratory Informatics Associate at Eli Lilly and Company

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.

Organization Overview:

Lilly has designed and built a new state of the art Parenteral, Device, and Packaging Assembly Facility in Raleigh-Durham North Carolina.  This is an exciting opportunity to help shape and further build out this new facility and supporting quality systems, specifically through supporting laboratory operations and ultimately bringing safe and efficacious medicine to patients.  

The Laboratory Informatics role is responsible for supporting laboratory operations through ensuring that electronic laboratory systems function per intended purpose and use, specifically relative to end user functionality and to system compliance with company and regulatory requirements.  Responsibilities will involve interacting with global and local IT support functions to develop/create master data and to configure/install local laboratory IT systems.  This role will also be responsible for troubleshooting, maintenance, upgrades, improvements, and corrections for laboratory IT systems.  This role will serve as a business representative for laboratory IT systems and will be responsible for mentoring laboratory personnel on the use of electronic lab systems as well as supporting internal and external audits as a laboratory IT system subject matter expert.

Key Objectives/Deliverables:

• Performs or supports Laboratory with the validation of laboratory equipment and software systems.
• Supports the establishment and maintenance of the validated state of software-based computerized systems in use in the laboratory.
• Lead site deployment and upgrades of QC laboratory IT systems such as Empower, MODA, Darwin LIMS, Biovia SmartLab®, NuGenesis ELN.
• Act as business owner and contact SME for QC laboratory IT systems.
• Responsible for collecting data and authoring periodic review documents for laboratory information systems.
• Provide oversight and support continuous improvement of quality systems as they relate to laboratory informatics.
• Apply knowledge of quality principles, cGMP, and laboratory systems towards the development and execution of local procedures, training courses, and practices.
• Assist in improvement of quality systems by creating or revising worksheets, developing, or updating laboratory execution system documentation, updating laboratory methods, and maintaining other lab documentation systems.
• Responsible for method management in the QC Laboratory, specific to scripted or coded methods.
• Supports and/or leads investigations, CAPA and change control initiatives.
• Develop training materials.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
• Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.

Requirements (Education, Experience, Training):

• Bachelor’s degree in a computer science, life science, or applied science with at least five (5) years of demonstrated relevant experience in a GMP lab.

Preferred attributes but not required:

• Experience with computer systems including Microsoft Office suite, laboratory information management systems (LIMS), laboratory execution systems (LES), electronic laboratory notebook (ELN) and various analytical instrument software systems.
• Investigation and deviation management experience.
• Experience with LabVantage and Kneat systems.
• Demonstrated proficiency in computer system validation.
• Experience with compliance requirements and regulatory expectations.
• Demonstrated accuracy and proficiency in analytical skills.
• Strong oral and written communication skills and demonstrated through documentation and presentation skills.
• Demonstrated strong interpersonal interaction skills.

Other Information:

• Tasks may require repetitive motion and standing for long periods of time.
• 8-hour days – Monday through Friday
• May require support outside of regular schedule (weekend days or off-hours) in support of continuous (24/7) manufacturing operations.
• Applicant will work in various areas within the site.  Some allergens are present in the parenteral plant. Mobility requirements and exposure to allergens should be considered when applying for this position.
• Minimal travel required.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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