Sr. Associate, QA Analytical; R2 – R3

Sr. Associate, QA Analytical

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.

Eli Lilly and Company seeks a Sr. Associate, QA Analytical (R2 – R3), to provide quality assurance analytical oversight for Product Research & Development (PR&D) and associated collaboration partners. Provide quality oversight for molecule testing labs, analytical equipment, perform audits and lab walkthroughs, and assessments of quality documentation and data. Ensure that quality systems are in place, utilized, and in a state of control.

Facilitate quality improvement initiatives, and the implementation of new quality standards. Assess potential impact of incidents and ensure appropriate review is conducted for deviations, change controls, and out of specification results. Perform quality assurance review of GMP documentation and ensure compliance with internal standards and applicable regulations.

Position requires a Bachelor's degree in Pharmacy, Chemistry, Life Sciences, Engineering, or a related field, and 4 years of experience with quality assurance and control in a pharmaceutical setting. Experience must include a minimum of: 1 year of experience with conducting comprehensive document reviews, including manufacturing batch records, quality control methods, protocols, reports, and validation documents; 1 year of experience with review and approval of method validation and technology transfer documents in compliance with ICH and FDA guidance;

1 year of experience with review of logbooks, QA batch disposition, and QA support; 1 year of experience with supporting QA for contract manufacturing organizations; 1 year of experience with reviewing and supporting QA equipment validation documents, installation qualification, operational qualification, performance qualification, and the maintenance and calibration of equipment. Up to 10% domestic and international travel required.

Job location:

Indianapolis, IN.

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 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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $ - $ per year.

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).