- Medtronic (Warsaw, IN)
- …improving patient outcomes. You will be responsible for tracking, documenting, and managing CAPA records within the Quality Management System (QMS), ensuring all ... teams to determine effective corrective and preventive actions. + Track, document, and manage CAPA records in the Quality Management System (QMS). + Monitor the… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …and preventive actions (CAPAs). + Monitor audit trends and escalate recurring issues to senior leadership. ** Quality Systems & Compliance** + Support the ... **Job Summary** The Senior Manager of Global Quality Management...implementation and continuous improvement of clinical quality systems , SOPs, and policies. + Assist… more
- Oracle (Indianapolis, IN)
- …Oracle Government Defense Intelligence (GDI) division. **Responsibilities** **Responsibilities** Our Senior engineers are technical leaders in our organization. They ... junior engineers as well as collaborating with the most senior architects; someone who knows how to balance speed...architects; someone who knows how to balance speed and quality with iterative and incremental improvements. You will help… more
- Merck (Indianapolis, IN)
- …clinical research including at least 2 years with developing and managing clinical quality systems and management of regulatory inspections. + Profound knowledge ... and comprehension of clinical development programs, clinical trial processes as well as quality management systems and quality control tools. + Expert… more
- Lilly (Indianapolis, IN)
- …increased technical capacity across the network. **Position Brand Description:** The Director/ Senior Director, Global Process Owner for Sterility Assurance, as a ... Manufacturing Sciences, Sterility Assurance team, will establish and maintain the global quality system procedural requirements for a Level 2 Process related to… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …to both small molecule and biologics. + Strong knowledge of GxP regulations, quality systems , and risk management principles. + Proven experience in operational ... on key risk indicators and escalate critical risks to senior leadership. **Global Quality System Processes** +...and manage multiple priorities. Preferred + Experience with global quality systems platforms (eg, Veeva, TrackWise). +… more
- Bristol Myers Squibb (Indianapolis, IN)
- …implement new processes and onboarding of new technologies, including advanced isolator systems . * Provide senior -level validation oversight and support for ... aims to be the global leader in radiopharmaceuticals. **Summary** The Senior Validation Engineer will lead validation efforts to support the Radiopharmaceutical… more
- Lilly (Indianapolis, IN)
- …well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance and current expectations, as well as align with business ... Support Central TS/MS Sterility assurance initiatives and programs including global quality standard development, sterility assurance work streams, new filling line… more
- Lilly (Indianapolis, IN)
- …well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also ... roles preferred. + 10+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems , execution and operation of … more