Senior Associate - LP1 QA

Quality Assurance Representative

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.

Lilly is currently constructing an advanced manufacturing facility for production of Active Pharmaceutical Ingredient (API) molecules located in Lebanon, Indiana, USA. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility, and the culture 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:

• BS in Engineering or science related field.
• 2+ year of cGMP 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.

Additional Skills/Preferences:

• Previous experience in pharmaceutical industry.
• Previous experience in QA, TS/MS QC or Engineering.
• Prior work with 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.
• Travel Percentage (%): N/A
• This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description.

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.

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 $65,250 - $169,400.