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QA Associate

4 months ago

Indianapolis, Indiana, United States Eli Lilly and Company Full time

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:

Product Research and Development (PRD) quality assurance (QA) supports the delivery of the Lilly pipeline by providing oversight of the manufacturing, packaging, and distribution of the medicines needed for clinical trials (CT). The CT Active Pharmaceutical Ingredient (API) team is responsible for the oversight of CT manufacturing executed internally within the K360 pilot plant located in Indianapolis at LTCN and at partner sites across the globe.

Responsibilities:

As the QA Associate, PRD SMDD API, you will provide quality and compliance support for API manufacturing specifically supporting SMDD (Synthetic Molecule Design & Development) which is performed at collaboration partners worldwide.

Support SMDD API Manufacturing, particularly as it relates to decisions associated with impact to the quality of products. Execute qualification and Quality oversight of API Collaboration Partner manufacturing which includes building and maintaining relationships and performing person-in-plant (PIP) visits. Perform pre- and post- review of batch production records utilized for manufacturing. Author, review, approve Change Controls and Deviation investigations. Assess the impact of change controls and events on the product and regulatory commitments. Ensure appropriate execution of Quality Systems to sustain compliance with regulatory requirements and good manufacturing practices. Support and/or evaluate the disposition of batches, including management and review of GMP documentation, analytical results and regulatory commitments. Ensure inspection readiness through compliance auditing, site self-assessments, GMP education, monitoring, establishing and enhancing Quality systems. Identify opportunities for and participate in continuous improvement. Basic Requirements: Bachelor's degree in engineering, pharmacy, or science-related field At least 2 years' experience supporting cGMP manufacturing (QA, TSMS, operations, engineering, auditing, etc.) Additional Skills/Preferences: Previous experience supporting cGMP API/drug substance manufacturing (QA, TSMS, operations, engineering, auditing, etc.) Previous QA experience Proven ability to influence without direct authority both internally and externally. Experience with computer systems (i.e., TrackWise, Veeva, SAP, Excel, PowerPoint, PowerBI) Additional Information: On-site, day shift, position located in Indianapolis (LTCN) with expectation of 50% on-site but flexibility given to the days. After hour support may be required depending on CP/business need Occasional travel (