- Cardinal Health (Indianapolis, IN)
- … quality and compliance. + Provides ideas for continuous improvement of the GMP Quality Management System. + Escalates complex issues to management in a ... standards for raw material, work in process, and finished products. + Champion Quality , GMP compliance and EHS/Radiation Safety practices. + Develop and lead … more
- Cardinal Health (Indianapolis, IN)
- …evaluate their potential impact on product quality and compliance + Champion Quality , GMP compliance and EHS/Radiation Safety practices + Ability to network ... Performs real-time QA review of batch documentation and other GMP related documents. + Issuance and reconciliation of product...and functional units to achieve positive outcomes. + Assists Quality Management with FDA and other regulatory… more
- Novo Nordisk (Bloomington, IN)
- …and/or deviations as required when observed on the floor + Provides dedicated quality floor oversight of GMP operations for the manufacture of master/working ... to embark on the opportunity to help improve the quality of life for millions of people around the...This role's primary function is to ensure compliance with FDA and other regulatory agency requirements as well as… more
- Lilly (Indianapolis, IN)
- …Logistics Quality Assurance, is a Quality professional with expertise in GMP quality assurance and DSCSA compliance. The Sr. Director ensures that DSCSA ... Leadership: Define and execute the company's DSCSA compliance roadmap, aligning with FDA requirements and corporate quality objectives. + Enterprise Compliance… more
- Bristol Myers Squibb (Indianapolis, IN)
- …and laboratory equipment/instrumentation and the application and interpretation of most-relevant GMP concepts and compendia requirements (eg US FDA , CFR, ... The Senior Manager, QA for QC is responsible for quality oversight of the Quality Control (QC)...regulations and guidance. . Knowledge and proven experience in FDA , EMA, or other regulatory authority. . Demonstrated leadership,… more
- Trane Technologies (Noblesville, IN)
- …as needed. Ensure that device history records are completed according to FDA GMP requirements. Complete nonconformance records according to established ... what's possible for a sustainable world. **Job Summary：** The Quality Auditor: . Promotes Helmer values as demonstrated in...procedures and GMP requirements. . Troubleshoot equipment failures. . Various assembly… more
- Abbott (Westfield, IN)
- …2 years of Software Quality Engineering experience + Detailed knowledge of FDA , GMP , IEEE 1012 and ISO 13485. Advanced computer skills, including ... colleagues serve people in more than 160 countries. **Engineer II Software Quality ** **About Abbott** Abbott is a global healthcare leader, creating breakthrough… more
- Novo Nordisk (Bloomington, IN)
- …automated manufacturing equipment. + Partner with commissioning and validation teams to meet FDA GMP compliance. + Draft, revise, and maintain standard operating ... to embark on the opportunity to help improve the quality of life for millions of people around the...and continuous improvement of automation systems that support our GMP manufacturing operations. This position focuses on process control… more
- Lilly (Indianapolis, IN)
- …validation, and compliance within regulated environments. + Experience supporting GMP manufacturing or quality laboratories, preferably related to ... to support its Global API Expansion Project. This role will provide quality assurance expertise in the implementation, validation, ongoing maintenance, and lifecycle… more
- Catalent Pharma Solutions (Greendale, IN)
- …Food Quality Plan (FQP) standards. Responsible for ensuring compliance to FDA and cGMP standards for Quality Control, including continuous training. + ... Ability to communicate with all line level positions and management. + Knowledge of GMP and Quality systems. + The employee must be able to lift and/or move up… more