Stability Coordinator - QA

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.

Organization Overview:
To provide stability program support to the Lilly Concord manufacturing site, maintain quality systems, and GMP compliance.  Stability Coordinator - QA provides assistance and guidance in deviation investigations, change control proposals, procedures, validations, and protocols.  The Stability Coordinator - QA's position is ensuring for maintaining GMP compliance and the safety of our medicines.Key Responsibilities:

Safety & Compliance

• Adhere to all safety policies and help maintain a safe work environment.

• Support HSE corporate and site-specific goals.

Stability Study Oversight

• Initiate, author, and obtain approval for stability protocols and studies.

• Manage and monitor stability studies for marketed device assembly, packaging, parenteral products at Lilly Concord site

• Ensure all study modifications comply with established procedures.

Deviation & Investigation Support

• Participate in deviation investigations and change control activities.

• Provide stability data and graphical summaries to support manufacturing investigations.

• Write and review deviation records, change controls, and support associated documentation.

Regulatory & Inspection Readiness

• Participate in self-led audits and regulatory agency inspections.

• Compile and distribute stability data packages to authorized stakeholders (e.g., Site Regulatory Affairs).

• Contribute to the stability sections of regulatory submissions.

Subject Matter Expertise & Training

• Serve as a content expert and reviewer for SOPs related to marketed drug products and stability programs.

• Train site personnel on stability-related topics and participate in relevant committee discussions.

Operational Support

• Monitor and forecast stability chamber capacity and scheduling needs.

• Provide primary support for sample management and temperature excursion/alarm responses.

Basic Qualifications:

Additional Skills/Preferences:

• Familiarity with Lilly systems: LabVantage, Darwin, Veeva, TrackWise, SAP.

• Proficiency in Microsoft Office (Word, Excel, PowerPoint).

• Experience in analytical labs, QA, or product development settings.

• Working knowledge of current Good Manufacturing Practices (cGMP).

• Flexibility to support overtime as needed.

Additional Information:

• Travel up to 10% may be required

• Occasional off-shift work may be required

• This position is expected to be on-site full time in alignment with hybrid work policy

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.

#WeAreLilly