Associate - Quality Assurance - Process

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.

Patients are at the center of everything we do at Lilly. We are currently hiring a Associate Quality Assurance.

This role supports critical work that helps bring medicines and solutions to patients responsibly and efficiently. #WeAreLilly

Scope

This position provides experienced Quality Assurance support to a 24/7 manufacturing operation, ensuring compliance with Quality Systems, Good Manufacturing Practices (GMP), and applicable regulatory requirements. The Associate, Quality Assurance is expected to apply solid technical knowledge, practical experience, and independent quality judgment while supporting deviation and laboratory investigations, change control proposals, procedures and master formula revisions, qualification and validation activities, and batch disposition.

The role requires an individual who is comfortable working in a fast‑paced manufacturing environment, supporting production activities directly on the floor, and making quality decisions that impact product quality and continuity of operations, while operating with limited supervision.

Main Responsibilities

• Provide Quality Assurance support to production floor activities within a 24/7 manufacturing environment, including on‑site support as required.
• Review and approve batch production records and perform batch disposition activities with accountability for quality decisions.
• Review and approve investigations, as appropriate, ensuring robust Root Cause Analysis and effective CAPA implementation.
• Provide guidance to manufacturing personnel related to data integrity practices and quality systems.
• Effectively write, review, and/or approve technical and quality documentation to ensure quality attributes and compliance requirements are met.
• Provide guidance to manufacturing personnel related to applicable regulations (BLA CFR 600 series preferred).
• Support and actively participate in regulatory inspections and internal audits.
• Demonstrate working knowledge and hands‑on experience in Cleaning Processes, Cleaning Validation, Process Qualification, Equipment Qualification, Process Validation, Contamination Control, Environmental Control of Clean Rooms, and Method Validation.
• Apply Risk Assessment tools and participate in FMEAs as required.
• Actively participate in Gemba Walks, manufacturing area inspections, and verification of procedural adherence on the production floor.
• Serve as a liaison between Manufacturing and other Quality and support functions (QC Labs, Compliance, Incoming, Engineering, Automation, Technical Services, Utilities, etc.).
• Interpret and apply quality standards and regulatory requirements to different operational scenarios.

Basic Requirements

• Bachelor of Science in Chemical Engineering, Biochemistry, Biotechnology, or related scientific discipline.
• Minimum of seven (7) years of relevant, hands‑on Quality Assurance experience supporting Manufacturing Operations, Compliance/Audit, Quality Systems, QA for Quality Control, and/or Technical Services / Manufacturing Science.
• Bilingual (Spanish and English).
• Strong written and verbal communication skills.
• Demonstrated ability to collaborate cross‑functionally with multiple levels of the organization.
• Ability to organize, prioritize, and manage multiple tasks and objectives simultaneously.
• Strong attention to detail and ability to identify discrepancies and improvement opportunities.
• Ability to make sound quality decisions in a fast‑paced manufacturing environment.
• Willingness to exercise sound judgment and be appropriately assertive when quality or compliance is at risk.
• Ability to work with minimal supervision.
• Demonstrated decision‑making, problem‑solving, organizational, and critical‑thinking skills.
• Ability to share knowledge and support training of others.
• Strong compliance mindset and working knowledge of current Good Manufacturing Practices (cGMPs).
• Technical writing skills, including investigation and root cause documentation.
• Computer literate.
• Must be available to support a 24/7 manufacturing operation.
• Willingness and ability to provide frequent on‑call support, including responsiveness to phone calls and operational needs outside of regular business hours, such as nights, weekends, and holidays, to ensure continuity of manufacturing operations.
• Flexibility to work extended hours and irregular schedules when business needs require.
• Availability to support other Quality Assurance areas (QA Operations, QA for QC, Compliance) based on business needs.

Important Notice: In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees. The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law. Marijuana is considered unauthorized by Lilly.

"Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1."

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.

#WeAreLilly