Associate - QA Master Data Steward

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:

This role acts as a data steward in SAP and LIMS for specifications. This role will develop these programs for the new LP1 facility in accordance with GQS guidelines and the IT systems in use at the LP1 plant.

Responsibilities:

• Develop and provide oversight to the Specification program

• Manage master data in SAP and LIMS at startup and routine manufacturing

• Support data management for change controls and deviations

• Prepare for and participate in internal and external regulatory inspections

• Acts as a liaison for US and OUS customers toward resolution of concerns from customers.

Basic Requirements:

• BS in Engineering or science related field

• 3+ years in pharmaceutical industry

• 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

• Previous experience with root cause investigations

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. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

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