Associate QA Representative - Peptide Manufacturing

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

Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN (Lilly Lebanon API). This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.

Job

Position Overview

The Quality Assurance representative provides support to LP1 API Operations manufacturing and ensures quality systems and GMP compliance. The QA representative provides assistance and guidance in deviation investigations, change control proposals, procedure and master production recipe revisions, validations and batch dispositions. The QA representative's position is essential for maintaining quality systems, ensuring GMP compliance and in the preparation for inspections by various regulatory agencies.

Responsibilities

* Provide direct quality oversight to LP1 manufacturing and assist others in interpretation of regulatory and corporate requirements.

* Provide quality guidance, technical support and recommendations to equipment and process issues and continuous improvement initiatives.

* Work with cross functional teams to implement QA objectives.

* Prepare for and participate in internal and external regulatory inspections.

Basic Requirements

* Bachelors Degree in Engineering or science related field.

* 1+ years manufacturing experience.

* 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.

Additional Skills/Preferences

* Previous experience in pharmaceutical industry

* Previous experience in QA, TS/MS QC or Engineering

* Prior work with cGMPs or external regulations

* Demonstrated strong oral and written communication and interpersonal skills.

* Demonstrated decision making and problem solving skills

Additional Information

* The normal schedule for this position is Monday-Friday, 8 hours/day. However, critical situations may require additional support beyond this normal schedule.

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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

$65,250 - $169,400

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…