Informatics Specialist

100 Eli Lilly and Company; Concord (NC); On-site; USD 65,000 - 169,000; Full time

Benefits offered by this job

Company-sponsored 401(k)

Pension

Vacation benefits

Medical, dental, Vision benefits

Job summary

Eli Lilly and Company is seeking a QC Laboratory Informatics Specialist to support laboratory IT systems, ensuring data integrity and regulatory compliance in a GMP setting. The role includes configuring systems, validating software, and mentoring peers across global and site IT teams.

Responsibilities focus on deploying and maintaining LabVantage LIMS and related tools, supporting audits, and driving continuous improvement in laboratory information systems within the QC environment.

Qualifications

• Bachelor’s degree in computer science, life science, or applied science.
• IT systems experience with installation, qualification, and data population.
• Minimum 3 years in a GMP laboratory.
• Authorized to work in the United States full-time.

Responsibilities

• Validate laboratory equipment and software systems.
• Maintain validated state of software-based systems in the lab.
• Deploy and upgrade QC laboratory IT systems (LabVantage LIMS, Empower, MODA, NuGenesis ELN, SDMS).
• Ensure data integrity and act as SME for QC lab IT systems.
• Support audits and continuous quality system improvements.

Skills

IT systems

LIMS LabVantage

Data integrity

GxP compliance

Education

Bachelor's degree in computer science or life sciences

Tools

LabVantage LIMS

MODA

NuGenesis ELN

Empower

Job description

About the Role

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Responsibilities

The QC Laboratory Informatics Specialist role is responsible for supporting laboratory operations through ensuring that electronic laboratory systems function per intended purpose and use, specifically related to end user functionality and to system compliance with company and regulatory requirements.

Responsibilities will initially involve interacting with global and local IT support functions to populate master data, configure systems, and assist with installing and qualifying laboratory IT systems such as LabVantage LIMS, MODA, NuGenesis ELN and SDMS, Empower, and other laboratory systems. The role will evolve into monitoring, execution and maintenance of the Laboratory IT Systems for the QC laboratory with an emphasis on continuous improvement and a focus on data integrity. This role will serve as business representative for laboratory IT systems and will be responsible for mentoring and educating peers on the use of laboratory systems and equipment, oversight for management reviews, laboratory metrics and laboratory documentation as well as supporting internal and external audits as a laboratory IT system subject matter expert.

Key Objectives / Deliverables

• Performs and/or supports the 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 within the laboratory.
• Leads and/or supports site deployment and upgrades of QC laboratory IT systems such as LabVantage LIMS, Empower, MODA, NuGenesis ELN and SDMS.
• Ensures data integrity by design within the QC laboratory.
• Acts as QC laboratory data integrity local representative.
• Partners and builds relationships with Global Quality Laboratory Network, Global and Site IT team members.
• Acts as a contact SME for QC laboratory IT systems.
• Performs non-terminal record monitoring activities.
• Supports audit trail discrepancies if found during system audit trail review.
• Supports continuous improvement of quality systems as they relate to the QC laboratory.
• Applies knowledge of quality principles, cGMP, and laboratory systems towards the development and execution of local procedures, training courses, and practices.
• Assists in improvement of quality systems by creating or revising worksheets, developing or updating laboratory execution system documentation, updating laboratory methods, and maintaining other laboratory documentation systems.
• Supports audit and inspection activities for the laboratory.
• Implements and complies with corporate, site, and laboratory safety standards.

Basic Qualifications

• Bachelor’s degree in a computer science, life science, or applied science field.
• IT systems experience (installation and qualification of laboratory IT systems, population of master data, and configuration of systems).
• Minimum 3 years experience in a GMP laboratory.
• Qualified applicants must be authorized to work in the United States on a full‑time basis.

Additional Skills / Preferences

• Master’s degree
• Proficiency with computer systems including Microsoft Office products, LabVantage LIMS, Laboratory Execution Systems, chromatography systems, electronic laboratory notebook systems including implementation of systems.
• Experience operating or implementing laboratory IT systems including LIMS and Automated Lab Execution systems.
• Experience with master data management activities including specifications, test methods, sample plans, and product configurations within LabVantage.
• Experience with performing data migrations and master data transfers across environments (DEV/TEST or STAGE/PROD).
• Investigation and deviation management experience.
• Demonstrated proficiency in computer system validation.
• Experience with compliance requirements and regulatory expectations.
• Excellent oral and written communication skills and demonstrated through documentation and presentation skills.
• Demonstrated accuracy and proficiency in analytical skills.
• Ability to work in a laboratory environment including wearing appropriate PPE and other safety related equipment or considerations.
• Previous experience with cross‑function leadership utilizing problem‑solving and decision‑making skills.

Additional 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.

Compensation

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400. Full‑time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

Benefits Program

• 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
• Well‑being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

EEO / Diversity Statement

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Employee Resource Groups (ERGs)

• Africa, Middle East, Central Asia (AMECA)
• Black Employees at Lilly (BE@Lilly)
• Chinese Culture Network (CCN)
• EnAble
• Evolve
• Lilly Indian Network (LIN)
• Organization of Latinx at Lilly (OLA)
• Pride (LGBTQ+ Allies)
• Veterans Leadership Network (VLN)
• Women’s Initiative for Leading at Lilly (WILL)

Accommodation for Individuals with Disabilities

In addition to the aforementioned introductory accommodations, Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Final Note

#WeAreLilly At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #WeAreLilly