Lilly Infrastructure Chemist, Microbiologist, or Biologist - QC in United States
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 39,000 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.
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.
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 Infrastructure 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 IT support functions to populate master data, configure, and assist at installing laboratory IT systems. It will evolve into monitoring, execution, maintenance, and continuous improvement of the Laboratory Quality Systems for Parenteral QC. 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.
Collect and report metrics related to quality processes
Lead site deployment and upgrades of QC laboratory systems such as Empower, Darwin, SmartLab®, NuGenesis
Act as business representative and contact SME for QC laboratory systems
Responsible for collecting data and authoring management review documents for laboratory quality systems
Provide oversight and support continuous improvement of quality systems
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
Demonstrated accuracy and proficiency in analytical skills.
Demonstrated strong problem-solving 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.
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
- Bachelor (4 year College) degree in chemistry, microbiology or biology and at least 5 years of demonstrated relevant experience in a GMP lab.
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.
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.
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!