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Lilly Laboratory Informatics Support - QC in Research Triangle Park, North Carolina

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 35,000 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.

Company Overview:

Lilly is a fortune 500 company in operation for over 140 years creating high-quality medicines for our patients while living our company values of Integrity, Excellence, and Respect for People in everything that we do.

Organization Overview:

Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Raleigh-Durham North Carolina. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The Quality Control Laboratory assures patients worldwide of safe and efficacious drug and device products, through effective execution of product testing.

The Laboratory Informatics role is responsible for monitoring laboratory performance to ensure that the QC laboratory maintains a state of control regarding the generation and reporting of analytical data. Responsibilities will initially involve interacting with global and local IT support functions to populate master data, configure, and assist at installing laboratory IT systems such as ELN, LES, and LIMS. The role will evolve into monitoring, execution, maintenance, and continuous improvement of the Laboratory IT Systems for the QC lab with an emphasis on continuous improvement, especially in regard to data integrity. This role will serve a business representative for laboratory IT systems and will be responsible for mentoring, educating peers on the use of lab systems, supporting audits, and oversight for Management reviews, laboratory metrics, and laboratory documentation.

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 lab

  • Lead site deployment and upgrades of QC laboratory IT systems such as Empower, Darwin, SmartLab®, NuGenesis

  • Act as business owner and contact SME for QC laboratory IT systems

  • Responsible for collecting data and authoring management review documents for laboratory quality systems

  • Provide oversight and support continuous improvement of quality systems as they relate to the QC lab

  • 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

  • Manage and support audit and inspection activities for the laboratory

  • Responsible for method management in the QC Laboratory

  • Performs and mentors others in change control, analytical investigations, root cause investigations, and activity planning

  • Implement and comply with corporate, site, and laboratory safety standards

  • Develop training materials

  • Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Minimum Requirements:

  • Bachelor (4 year College) degree in computer science, information systems, chemistry, microbiology, biology, or related scienc and at least 5 years of demonstrated relevant experience in a GMP lab.

Additional Preferences:

  • Demonstrated proficiency in computer system validation

  • Proficiency with computer systems including Microsoft Office products, LIMS, Laboratory Execution Systems, chromatography systems, electronic laboratory notebook systems.

  • Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.

  • Deep understanding of 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.

  • Ability to focus on continuous improvement.

Other Information:

  • Tasks may require repetitive motion and standing for long periods of time

  • 8 hour days – Monday through Friday

  • Occasional shift work when required within the lab

  • Required to be available off shift and respond to operational issues.

  • 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 ( LillyRecruitingCompliance@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.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

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