Principal Scientist, Quality Assurance

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.

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 Overview:

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced quality assurance associates to support our growth in Lilly Kenosha County (LKC). This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

The Principal Scientist, Quality Assurance provides daily oversight, assistance, and guidance to the site-based process team supporting one of the following manufacturing areas:

• Equipment Prep and Formulation
• Parenteral Filling
• Visual Inspection

The QA representative supporting the process team provides guidance on issues such as non-conformance investigations, change controls, procedures, validations, batch disposition, and commissioning and qualification activities. The individual in this role advises and provides support for other floor support QA Representatives. This position is essential for maintaining GMP compliance and ensuring inspection readiness.

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.
• Leads, mentors, and coaches operations and support personnel on quality matters.
• Ensures regular presence in operational areas to monitor GMP programs and quality systems.
• Serves as the Quality point of contact on the local process team, as outlined in Lilly’s Manufacturing Standards for Operational Excellence.
• Assess and triages deviations that occur within the local process team.
• Works with Lilly support groups and external partners to resolve or provide advice on product related issues.
• Participates in self-led inspections and provides support during regulatory inspections.
• Initiates, reviews, and approves documents to ensure quality attributes are met (e.g., deviations, procedures, technical studies, validation protocols, change controls, engineering documents)
• Participates in continuous improvement projects to help improve productivity within the local process team or quality organization.
• Approves commissioning, qualification, and validation documents for computer systems and equipment to ensure compliance with quality standards.
• Networks with Global Parenteral Network sites to benchmark and replicate best practices.

Basic Requirements:

• Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience.
• Minimum 3 years in the pharmaceutical industry with specific batch disposition experience
• On-site presence required.

Additional Skills/Preferences:

• Demonstrated understanding of cGMP regulations.
• Previous experience in GMP production environments.
• Previous experience with C&Q and Validation oversight including automation and computer systems validation
• Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing
• Proficiency with applicable computer systems
• Demonstrated strong oral and written communication skills
• Demonstrated interpersonal skills and the ability to work as a team
• Root cause analysis/troubleshooting skills
• Demonstrated attention to detail and ability to maintain quality systems
• Proven ability to work independently or as part of a Team to resolve an issue
• Technical Writing and Communication Skills
• ASQ Certification
• Computer System Quality Assurance (CSQA) experience
• Previous experience with Manufacturing Execution Systems.
• Previous use of KNEAT – or other electronic validation software

Additional Information:

• Primary location is Kenosha County, Wisconsin
• Ability to travel (approximately 10 %)
• Ability to work overtime as required.

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.

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.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our 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 for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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