Eli Lilly and Company seeks a Sr. Associate, QA Analytical (R2 – R3), to provide quality assurance analytical oversight for Product Research & Development (PR&D) and associated collaboration partners. Provide quality oversight for molecule testing labs, analytical equipment, perform audits and lab walkthroughs, and assessments of quality documentation and data. Ensure that quality systems are in place, utilized, and in a state of control. Facilitate quality improvement initiatives, and the implementation of new quality standards. Assess potential impact of incidents and ensure appropriate review is conducted for deviations, change controls, and out of specification results. Perform quality assurance review of GMP documentation and ensure compliance with internal standards and applicable regulations. #LI-DNI
Position requires a Bachelor's degree in Pharmacy, Chemistry, Life Sciences, Engineering, or a related field, and 4 years of experience with quality assurance and control in a pharmaceutical setting. Experience must include a minimum of: 1 year of experience with conducting comprehensive document reviews, including manufacturing batch records, quality control methods, protocols, reports, and validation documents; 1 year of experience with review and approval of method validation and technology transfer documents in compliance with ICH and FDA guidance; 1 year of experience with review of logbooks, QA batch disposition, and QA support; 1 year of experience with supporting QA for contract manufacturing organizations; 1 year of experience with reviewing and supporting QA equipment validation documents, installation qualification, operational qualification, performance qualification, and the maintenance and calibration of equipment. Up to 10% domestic and international travel required. #LI-DNI
To apply, please visit https://jobsearch.lilly.com/ and enter job requisition number R-107946 when prompted. Alternatively, please send your resume, cover letter, and a copy of the ad to: Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285.
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