- Cook Medical (Ellettsville, IN)
- …production controls (eg qualification, process capability, sampling plans, validation , etc.)* Perform investigation of product nonconformance/complaints, root cause ... as necessary * May interface with internal or 3rd party audits (eg FDA , Notified Body, etc.)* Drive continuous improvement efforts through facilitating, leading, and… more
- Cook Medical (Bloomington, IN)
- …and test method development (design for manufacturing/assembly, process validation , process capability, lean manufacturing, equipment selection and qualification, ... + Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements. Qualifications +… more
- Lilly (Indianapolis, IN)
- …program implementation + Have a comprehensive understanding of the cleaning validation process + Create Standardized Cleaning documentation + Support the development ... knowledge of cleaning equipment and cleaning regimes. + Knowledge of relevant FDA and EU regulations relating to equipment cleaning in small molecule manufacturing.… more
- Lilly (Indianapolis, IN)
- …equipment + 1+ years of experience in GMPs and computer systems validation (CSV) **Additional Skills/Preferences:** + Experience in serialization and full track and ... with stakeholders + Familiarity with industry standards such as GS1 and FDA DSCSA regulations System integration with enterprise resource planning (ERP, SAP+) and… more