Eli Lilly and Company seeks a Quality Control Associate (R1-R3) to provide technical support for pharmaceutical device testing. Provide quality control technical support for design verifications, process validations, stability testing, and batch release testing. Investigate quality observations and deviations using root cause analysis. Support change management processes through impact analyses. Review and approve Good Manufacturing Practices (GMP) laboratory data and documentation, including protocols, methods, technical reports, procedures, sampling plans, and rework, retest, and resample instructions. Perform comprehensive technical review of lot release testing data. Participate in regulatory agency and internal inspections. #LI-DNI
Position requires Bachelor's degree in Biotechnology, Biomedical Engineering, or a closely related field and 1 year of experience with quality control laboratory operations and device testing. Experience must include a minimum of: 1 year of experience with quality control operations for parenteral products, dry products, or pharmaceutical devices; 1 year of experience with writing requirements documents and developing training materials; 1 year of experience with analytical lab equipment, including Zwick, CADI, and MicroVu; 1 year of experience with documentation management systems, including Veeva and Quality Docs; and 1 year of experience with quality systems and regulatory requirements, including cGMP, 21 CFR 820, ISO 13485, and Medical Device Directive. Up to 5% domestic and international travel required. #LI-DNI
Job location: Indianapolis, IN. To apply, please visit https://jobsearch.lilly.com/ and enter job requisition number R-1034395 when prompted. Alternatively, please send your resume, cover letter, and a copy of the ad to: Matthew Tenerante, Corporate Center, Indianapolis, IN 46285.
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