- Elara Caring (Indianapolis, IN)
- …at the Right Time, in the Right Place. **Job Description:** ** Clinical Risk and Safety Investigations Specialist** Remote/Monday through Friday Nurse ... their health journey. Elara is looking for an experienced ** Clinical Risk and Safety Investigations Specialist** with home base care experience. In this… more
- Novo Nordisk (Bloomington, IN)
- …where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The ... in this area are required to wear scrubs and/or coveralls, gloves, hairnet, safety glasses, and steel toed shoes. Secondary - The Secondary Manufacturing department… more
- Novo Nordisk (Bloomington, IN)
- …where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The ... in this area are required to wear scrubs and/or coveralls, gloves, hairnet, safety glasses, and steel toed shoes. Secondary - The Secondary Manufacturing department… more
- Novo Nordisk (Bloomington, IN)
- …where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The ... . Actively participates in team meetings and/or training sessions . Follow all safety and environmental requirements in the performance of duties . Other duties as… more
- Novo Nordisk (Bloomington, IN)
- …where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The ... + Other duties as assigned Investigation Team: + Ensure timely completion of investigations through the following activities in Trackwise to include but not limited… more
- Wolters Kluwer (Indianapolis, IN)
- …action (CAPA)plans, with oversight of complaint trending, post-market surveillance, clinical evaluation, design control, and risk management activities. ... You will lead and participate in projects to enhance and maintain safety and performance of on-market products, interfacing with supplier and internal groups to… more
- Novo Nordisk (Bloomington, IN)
- …where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The ... and reports o Manages the oversight, review and approval of deviation investigations and change controls pertaining to CGMP production and testing o Supports… more
- Lilly (Indianapolis, IN)
- …Management:** + Provide technical leadership and problem-solving skills for Health, Safety and Environmental incident investigations . + Lead and/or participate ... Matter Expert on processing equipment in a clean room (classified environment) for clinical and commercial operations. The role will be part of the cross functional… more
- Bristol Myers Squibb (Indianapolis, IN)
- …supervising daily operations and managing its various components to support clinical and commercial production, while ensuring critical deliverables and timelines ... + Analyze and trend environmental and personnel monitoring data, conduct risk assessments, and develop and implement contamination control strategies to maintain… more
- Novo Nordisk (Bloomington, IN)
- …where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The ... + Gather and report area metrics + Perform supplier risk assessments + Support maintenance of the approved supplier...equipment, and material holds as appropriate + Follow all safety and environmental requirements in the performance of duties… more
- Lilly (Lebanon, IN)
- …and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be ... candidate will help to design, commission and start up the facility for both clinical and commercial supply. This is an exciting opportunity to help build a… more
- Novo Nordisk (Bloomington, IN)
- …where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The ... Procedures (SOPs); identifying improvement opportunities; assisting with change control, risk management, and corrective and preventive action processes + Supports… more
- Novo Nordisk (Bloomington, IN)
- …CAPA and disposition decisions + Gather and report area metrics + Perform supplier risk assessments + Follow all safety and environmental requirements in the ... where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The… more
- Novo Nordisk (Bloomington, IN)
- …where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The ... for continuous improvement to enhance operational efficiency, product quality, and safety within aseptic manufacturing. + Serve as a Subject Matter Expert… more
- Lilly (Indianapolis, IN)
- …timeline + Strong process safety knowledge, understanding of the basis of safety and risk assessmentswith an ability to react appropriately. + Flexible, ... innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact. The… more
- Novo Nordisk (Bloomington, IN)
- …where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The ... Reports to Supervisor. Essential Functions + Perform or leading risk assessments + Execute continued process validation and annual...closure + Drive to meet deadlines + Follow all safety and environmental requirements in the performance of duties… more
- Novo Nordisk (Bloomington, IN)
- …where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The ... problem-solving techniques to resolve more complex assignments + Perform process risk assessments to assess impact of proposed improvements + Participating in… more
- Bristol Myers Squibb (Indianapolis, IN)
- …RayzeBio Indianapolis site. + Champion a culture that embraces psychological and physical safety of employees in the work environment. + Champion a culture of ... deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge + Regularly… more