Quality Assurance Person in Plant - Drug Product External Manufacturing (Bloomington, IN)
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About The Position
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. This role is responsible for providing daily quality oversight at the Contract Manufacturers (CM) site. This role is located in person on site at the CM site the majority of the time. Additional responsibilities include providing assistance, and guidance to issues such as deviation investigations, change control proposals, procedure/ master formula revisions, and other duties associated with daily Contract Manufacturers (CM) activities. QA Person in Plant may be also responsible for final disposition of manufactured and/or packaged drug product batches. This role serves as DPEM QA primary contact to the CM for initial escalation and works with the JPT to ensure timely response for requests for information. They also ensure that batches meet specifications, are manufactured/packaged in accordance with validated processes and are compliant with cGMP requirements and regulatory requirements.
