- Lilly (Lebanon, IN)
- …build the processes and facility to enable a successful startup into GMP manufacturing operations. **Position Brand Description:** The Tank Farm and Solvent Recovery ... and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant… more
- Lilly (Lebanon, IN)
- …the processes and facility to enable a successful startup into GMP manufacturing operations. **Position Brand Description:** The Operators for API manufacturing ... and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant… more
- Ricoh Americas Corporation (Indianapolis, IN)
- …instructions for incoming contract manufacturing. Ensure compliance with ASTM, ISO 13485, FDA , and other standards for medical device manufacturing. Act as Subject ... Matter Expert for assigned processes; support audits (customer, ISO, FDA , internal). Collaborate on the design/fabrication of jigs, tools, fixtures, gauges, and… more
- Cardinal Health (Indianapolis, IN)
- …Quality records + Performs real-time QA review of batch documentation and other GMP related documents. + Issuance and reconciliation of product labels for production ... their potential impact on product quality and compliance + Champion Quality, GMP compliance and EHS/Radiation Safety practices + Ability to network across business… more
- Lilly (Indianapolis, IN)
- …staff, focusing on the visual inspection of parenteral products and adherence to GMP requirements. + Mentor junior staff and develop training materials to promote ... organization. **Compliance & Documentation** : + Ensure compliance with FDA and any other global applicable regulatory standards by...+ 10+ years of experience with parenterals in a GMP -regulated environment, with at least 5+ years of experience… more
- PDS Tech Commercial, Inc. (Indianapolis, IN)
- …reliability and compliance of critical production systems in a state-of-the-art GMP Radioligand Therapies facility, supporting the safe and high-quality production ... + 3+ years of hands-on plant maintenance experience in a regulated GMP environment. + Strong troubleshooting skills across mechanical, electrical, and utility… more
- PDS Tech Commercial, Inc. (Indianapolis, IN)
- …the reliable and compliant operation of critical production systems in a GMP Radioligand Therapies facility, supporting the safe and efficient production of ... + 5+ years of hands-on plant maintenance experience in a regulated GMP environment. + Strong troubleshooting skills across mechanical, electrical, and utility… more
- Novo Nordisk (Bloomington, IN)
- …employees and manages work load for operational area + Reviews and approves GMP documentations while ensuring safety and GMP quality compliance + Supports ... with 3+ years relevant experience required + Leadership experience preferred + GMP experience preferred + Technical Requirements: + Excellent written and verbal… more
- Novo Nordisk (Bloomington, IN)
- …Schedules employees and manages workload for operational area + Reviews and approves GMP documentations while ensuring safety and GMP quality compliance + ... - 4 years relevant experience preferred + Leadership Experience Required + GMP experience preferred + Technical Requirements: + Excellent written and verbal… more
- Novo Nordisk (Bloomington, IN)
- …Schedules employees and manages workload for operational area + Reviews and approves GMP documentations while ensuring safety and GMP quality compliance + ... - 4 years relevant experience preferred + Leadership Experience Required + GMP experience preferred + Technical Requirements: + Excellent written and verbal… more