Senior Associate, Quality Assurance - QA for QC

About the role

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. 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 Senior Associate, Quality Assurance – QA for QC provides quality oversight, assistance, and guidance to the Quality Control Laboratories on issues such as non-conformance investigations, change controls, procedure revisions, method activities (e.g., transfers, verifications, validation), and commissioning and qualification activities. This position is essential for maintaining GMP compliance and ensuring inspection readiness. Primary location is Kenosha County, Wisconsin. Ability to travel (approximately 10%). Ability to work overtime as required.

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 quality control laboratory personnel on quality matters.
• Supports the QA Compliance team and site in the execution of the site readiness plan with focus on right-first-time execution in the QC Laboratory.
• Reviews and approves laboratory instrument commissioning and qualification deliverables.
• Reviews and approves method deliverables including method transfers, verifications, and validations for QC Lab computer systems and equipment to ensure compliance with quality standards.
• Ensures regular presence in QC Lab areas to monitor GMP programs and quality systems.
• Serves as an active member on local lab team, as outlined in Lilly’s Manufacturing Standards for Operational Excellence, including participation with Lean Lab initiatives, daily huddle board and continuous improvement.
• Assess and triages deviations that occur within Quality Control.
• Works with Lilly support groups and external partners to resolve or provide advice on QC Lab related issues.
• Participates in self-led inspections and provides support during regulatory inspections.
• Works with the Global Quality Control laboratories and network personnel to benchmark and replicate best practices.
• Authors, reviews, and/or approves GMP documents in Quality Control to ensure quality attributes are met (e.g., deviations, procedures, technical studies, validation protocols, change controls).
• Participates in continuous improvement projects to help improve productivity within the local process team or quality organization.

Requirements

• Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience.
• Minimum 5 years in the pharmaceutical industry with specific Quality Control experience.
• On-site presence required.

Skills

• Demonstrated understanding of cGMP regulations.
• Previous experience in GMP production environments.
• Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing.
• Experience with LIMS, LES, SAP, Veeva QMS, Veeva Quality Docs.
• Proficiency with applicable laboratory management computer systems equivalent to MODA or LABVANTAGE.
• 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.