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, dedicated to discovering and delivering life‑changing medicines, improving disease understanding and management, and giving back to our communities through philanthropy and volunteerism. We put people first and look for individuals determined to make life better for people worldwide.
Position Overview:
Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and extend our exciting future. We are seeking experienced Quality Assurance Associates to support our growth in Kenosha County, Wisconsin, and provide an outstanding opportunity to contribute to new manufacturing investments and pioneering technologies.
Responsibilities:
Maintains responsibility for a safe work environment, leading safety initiatives, and working safely; accountable for supporting all Health, Safety, and Environmental Corporate and Site Goals.
Performs 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 in the lab.
Ensures data integrity by design within the QC laboratory.
Leads site deployment and upgrade of QC laboratory IT systems such as Empower, NuGenesis, MODA, and Labvantage.
Partners and builds relationships with Global Quality Laboratory Network and Global IT team members.
Acts as business owner and subject‑matter expert for QC laboratory IT systems.
Collects data and authors management review documents for the laboratory quality system.
Provides oversight and supports continuous improvement of quality systems as they relate to the QC lab.
Applies knowledge of quality principles, cGMP, and laboratory systems toward the development and execution of local procedures, training courses, and practices.
Assists in improvement of quality systems by creating or revising worksheets, updating laboratory methods, and maintaining other lab documentation systems.
Manages and supports audit and inspection activities for the laboratory.
Manages methods in the QC laboratory.
Performs and mentors others in change control, analytical investigations, root‑cause investigations, and activity planning.
Implements and complies with corporate, site, and laboratory safety standards.
Develops training materials.
Basic Requirements:
Bachelor’s degree in a science, engineering, or pharmaceutical‑related field of study or equivalent experience.
Minimum 6 years in the pharmaceutical industry with specific Quality Control and laboratory computer system experience.
On‑site presence required.
Additional Skills/Preferences:
Fluent in English.
Demonstrated understanding of cGMP regulations.
Previous experience in GMP production environments.
Proficiency with applicable computer systems.
Deep understanding of compliance requirements and regulatory expectations.
Demonstrated analytical skills.
Proficiency with Microsoft Office products, LIMS, Laboratory Execution Systems, chromatography systems, e‑lab notebook systems, and implementation of systems.
Ability to work in a lab environment, wearing appropriate PPE and safety equipment.
Excellent written and oral communication skills.
Previous LEAN experience: ability to drive continuous improvement.
Experience operating or implementing Lab IT systems including LIMS and automated execution systems.
Strong technical aptitude and ability to train and mentor others.
Project management experience.
Problem‑solving and decision‑making capability.
Technical writing skills.
Understanding of statistical tools and analyses.
Strong documentation skills and attention to detail.
Interpersonal skills and teamwork.
Root‑cause analysis/troubleshooting skills.
Ability to work independently or as part of a team to resolve issues.
Regulatory inspection readiness and execution experience.
Additional Information:
Primary location is Kenosha County, Wisconsin.
Ability to travel (approximately 10%).
Ability to work overtime as required.
This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. Consult with your supervisor regarding your actual job responsibilities.
Lilly is dedicated to helping individuals with disabilities actively engage in the workforce, ensuring equal opportunities. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.
Lilly is a proud 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.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage range for this position is $65,250 – $169,400.
Full‑time equivalent employees will also be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefits program, including a company‑sponsored 401(k), pension, vacation benefits, medical, dental, vision, prescription drug benefits, flexible benefits, life insurance, and well‑being benefits.