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.

　　Position Brand Description:

　　At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing, and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

　　The Lilly Manufacturing & Quality organization is actively looking for self-starters who like to solve problems. Are you passionate about driving meaningful change and harnessing modern technology to streamline manufacturing and lab operations? If so, please apply.

　　Come help us transform and modernize Quality Control processes at the Lilly Branchburg site!

　　Lilly has initiated a multi-year QC transformation program that will simplify and enhance QC Laboratory, then modernize lab operations with advanced technology and equipment in alignment with Lilly’s Lab of the future vision. This is part of a broader set of enterprise-wide programs focused on enabling unprecedented company growth and delivery of new modalities serving patients around the world.

　　What you’ll be doing:

　　The Lilly Branchburg site is looking for a QA Specialist for the local deployment of a modern enterprise Lab Information Management and Execution System. The role will involve QA oversight on design, monitoring, execution, maintenance, and continuous improvement of the Laboratory IT systems for the QC laboratories with an emphasis on analytical control strategy, data integrity and compliance.

　　You will be part of a highly skilled cross-functional dedicated team focused on execution of the following major phases of the program:

　　• Discovery phase - assess the current state of lab processes, perform gap analysis, and define the scope and integrated plan to deliver across all project workstreams.

　　• Build phase – execute the plan using the Agile methodology. This will involve development of the end-to-end product (Master Data, Process Flows, Procedures, Data Visualizations, Instrument Connections, etc.)

　　• Test & Deploy phase – Ensure the end-to-end product meets business need using robust validation and qualification processes, then deploy the product in line with approved change management plan, in close collaboration with QC laboratory analyst and technicians.

　　Specific responsibilities of the Quality Assurance Specialist include:

　　Provide consultation/education to business areas on the interpretation and practical implementation of the quality requirements associated with their area of expertise.

　　Responsible for assisting with the design, roll out, stabilization and technical and compliance support for new lab system(s) including but not limited to LIMS/LES (LabVantage), MODA, Electronic Laboratory Notebooks (NuGenesis) etc.

　　Participate in data integrity assessments and identify Data integrity risks in the system functionality, procedures, data mapping, records/data backup, archival and retention. Collaborate with cross functional teams as needed to ensure timely implementation.

　　Collaborate with QC on implementation and manage project changes and interventions to achieve project outputs.

　　Support the validation of software systems with a compliance and data integrity mindset.

　　Support updates made to laboratory methods and system documentation.

　　Escalate/communicate compliance status and data integrity risks to senior management and project teams.

　　Applies knowledge of quality principles, cGMP, and laboratory systems towards the development and execution of local procedures, training courses, and practices.

　　Execute project tasks as defined by project plan to meet the batch release timelines, ensuring reliable supply of medicines.

　　Support lab modernization project by benchmarking with industry and other Lilly sites and harmonize/implement best business practices.

　　How you will succeed:

　　• Be Bold - We are looking for individuals to tackle tough challenges and ability to work in a diverse team through translation of complex business requirements into robust business process and data solutions.

　　• Be Fast - We need someone who is willing to move at the pace that is in line with business, regulatory, and patient needs.

　　• Be Engaging - We need a team member who will be engaged in a broad and diverse team focused on streamlining business processes using automated solutions and new capabilities such as Artificial Intelligence and data integration using modern API platforms.

　　What You Should Bring:

　　Strong understanding of Quality Assurance and Quality Lab business processes.• Demonstrated abilities to assist in complex projects through the management of timelines, issues, and risks.• Experience understanding computer systems validation and system/software development Life cycle concepts.Basic Qualifications:

　　Bachelor’s degree in Science based and/or Technology field.

　　3+ years working in a GMP lab environment, Quality Assurance experience on supporting the laboratory systems is a plus.

　　Strong understanding of GxP and quality systems.

　　Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

　　Additional Preferences:

　　• Master’s degree in Science and/or Technology related field.

　　• Knowledge of Pharma, Quality Assurance, and Lab Operations.

　　• Solid skills in problem analysis and problem solving.

　　• Well-developed written and verbal communication skills.

　　• Proven teamwork/interpersonal skills.

　　• Passion for working on a team from diverse backgrounds.

　　Proficiency in planning and ability to carry out tasks individually and as a part of a team with minimal supervision.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 ( [email protected] ) 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.

　　Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

　　#WeAreLilly