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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:

As a **QA for QC Representative** , you will serve as the primary quality liaison for laboratory-related activities at external manufacturing sites. You’ll provide expert guidance on non-conformances, change controls, method transfers, specifications, validations, and more. This role is critical in maintaining GMP compliance, supporting regulatory inspections, and ensuring successful product launches.

Key Responsibilities:

Laboratory Oversight & Quality Leadership

+ Provide quality oversight and guidance for CM laboratory operations, ensuring alignment with Lilly standards and regulatory expectations.

+ Lead or support lab-related activities for new product, package, or CM launches.

+ Drive improvements in CM lab quality systems through technical leadership and project management.

+ Oversee the DPEM stability program, including protocol development, data review, and performance metrics.

+ Review and approve GMP lab documents (e.g., methods, validations, change controls, stability reports).

+ Support analytical method implementation, specification changes, and ongoing maintenance.

Compliance & Documentation

+ Ensure CM labs maintain a state of control and are inspection-ready at all times.

+ Conduct SOP assessments and track resolution of outstanding issues.

+ Participate in and support regulatory inspections and internal audits.

+ Create and manage Darwin/LIMS master data and input/verify lab data as needed.

+ Generate Certificates of Analysis and other documentation for internal/external stakeholders.

Collaboration & Communication

+ Build strong relationships with CM lab personnel and internal Lilly teams.

+ Serve as a key member of Joint Process Teams (JPTs), providing lab-related insights and support.

+ Partner with Lilly support groups to resolve product-related issues.

+ Provide technical guidance to DPEM QA Management and JPTs on lab issues and trends.

+ Participate in OOS investigations and contribute to Annual Product Reviews and Reports.

Basic Qualifications

+ Bachelor’s degree in Pharmacy, Chemistry, Biological Sciences, or STEM related degree

+ Minimum 3 years of experience in pharmaceutical Quality Control within a GMP-regulated lab environment.

Preferred Qualifications

+ Experience with electronic quality systems (e.g., Darwin/LIMS, GPCMS, CAPA, SAP, TrackWise).

+ Familiarity with Microbiology/Sterility Testing and product stability programs.

+ Knowledge of specification and materials/supplier management.

+ Strong project management, coaching, and mentoring skills.

+ Deep understanding of cGMPs, Global Quality Standards, and pharmaceutical manufacturing operations.

+ Excellent written and verbal communication skills.

+ Strong decision-making, problem-solving, and organizational abilities.

+ Ability to influence cross-functional teams and manage multiple priorities.

Additional Information:

+ Shift is days, but off-hours may be necessary to support operations.

+ Travel is possible, up to 30%.

+ Position is in Indianapolis, IN. Expectation of role is to be in the corporate office at least 4 days per week when not traveling.

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

$63,000 - $162,800

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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