- Abbott (Westfield, IN)
- …Our 114,000 colleagues serve people in more than 160 countries. ** Quality System & Regulatory Compliance Manager** **Working at Abbott** At Abbott, ... leadership in quality and regulatory compliance matters. The Quality System ...Manage all phases of external audits. + Serve as Quality Systems Subject Matter Expert and Generalist/Escort.… more
- Fresenius Medical Center (Carmel, IN)
- …ensuring appropriate actions taken to ensure required resolution. Demonstrates pride in the quality of work, regulatory compliance , and the environmental ... vision, core values and customer service philosophy. Adheres to the FMCNA Compliance Program, including following all regulatory and FMS policy requirements.… more
- Lilly (Lebanon, IN)
- …+ Adhere to all applicable procedures, cGLP, cGMPs, company policies, and any other quality or regulatory requirements. + Compliance with cleanroom gowning ... using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards,… more
- Lilly (Lebanon, IN)
- …supply. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The Quality Assurance Operational ... cGMP practices including good documentation practices, data integrity and regulatory compliance + Act as a cGMP...and QRM principals and ensuring the integration of Global Quality System requirements into the design +… more
- Lilly (Lebanon, IN)
- …systems within LP1 API manufacturing facility. This role ensures that all HVAC systems operate efficiently and comply with regulatory standards to maintain a ... miss reviews and incident notifications. Ensures proper housekeeping procedures are maintained. + Quality - + Responsible for team's compliance and meeting the … more
- Lilly (Lebanon, IN)
- …and computer system development/ validation methodologies to ensure regulatory compliance , consistency, and sustaining data integrity related activities ... in the site's processes, and validation/maintenance requirements to support regulatory compliance , consistency, and sustainment. **Responsibilities:** Deliver… more
- Lilly (Lebanon, IN)
- …equipment qualification support **Post** **Startup Phase:** + Ensure utility operations maintains compliance with all regulatory requirements at all times + ... data collection and analysis platforms that will deliver improvements in safety and quality , and process performance. This is a unique opportunity to be a part… more
- Lilly (Lebanon, IN)
- …documents for the laboratory quality system . + Supports continuous improvement of quality systems as they relate to the QC lab. + Applies knowledge of ... of systems ) **Additional Skills/Preferences:** + Deep understanding of compliance requirements and regulatory expectations + Demonstrated accuracy and… more
- Lilly (Lebanon, IN)
- …interact with other engineering, manufacturing, development, and other science professionals. ** Quality Assurance:** Develops and audit systems to ensure ... Science Overview:** + Ensuring reliability of our manufacturing and utility systems + Searching for and implementing continuous improvements + Maintaining our… more
- Lilly (Lebanon, IN)
- …supply. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The Quality Control Laboratory ... Wet Chemistry + Utilize sampling/testing equipment and supporting software and LIMS systems + Ensures compliance with current Good Manufacturing Practices (GMP)… more
- Lilly (Lebanon, IN)
- …GMP manufacturing through start up. **Responsibilities:** + Ensure utility operations maintains compliance with all regulatory requirements at all times. + ... order to safely and compliantly support the manufacturing of high- quality medicine. In the project delivery phase and startup...the production plan for the site. + Utility Operator Systems : Water Systems , Boilers, Nitrogen System… more
- Lilly (Lebanon, IN)
- …analysis to assure technical availability. + Work with process engineers to improve regulatory compliance , reliability, and safety. + Monitor and report assigned ... and repair mechanical, plumbing, structural, furniture, fire, life safety, and control systems . + Ensure plant equipment compliance . + Provide technical support… more
- Lilly (Lebanon, IN)
- …position will interact with Engineering, Manufacturing, Quality Assurance, Quality Control, Validation, Development, and Regulatory departments. Interaction ... systems . + Remain current on new industry and regulatory trends relating to cleaning equipment and cleaning regimes....implement TS/MS objectives and deliver on business plan and quality objectives. + Ensure a safe working environment through… more
- Abbott (Westfield, IN)
- …in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. + Complies with US Food and ... Our business purpose is to restore health and improve quality of life through the design and provision of...(eg, automated component attach operations; robotic and machine visual system , manual assembly, inspection, test and probe). + Supports… more
- Lilly (Lebanon, IN)
- …necessary, but also incorporating external experiences and learning. + Ensure regulatory compliance and operational excellence by supporting lean principles ... using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards,… more
- Lilly (Lebanon, IN)
- …into GMP manufacturing operations._ **Main Purpose and Objectives:** The Associate Director - Quality Control is part of the Lilly Lebanon API QC team for the ... optimizations. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for validation.… more
- Lilly (Lebanon, IN)
- …scale GMP manufacturing through start up. **Responsibilities:** + Ensure operations maintains compliance with all regulatory requirements at all times. + Ensure ... Solvent Recovery Operator will be responsible for tank farm operations, air emissions systems , rail car loading/unloading, and solvent recovery systems . The role… more
- Lilly (Lebanon, IN)
- …Develop investigational testing protocols and perform testing as required. + Improve lab quality systems ; develop content, review, and approve SOPs and training ... and other safety related equipment or considerations. + Deep understanding of compliance requirements and regulatory expectations. Lilly is dedicated to helping… more
- Ascension Health (Zionsville, IN)
- …Ensure that clinical programs are in compliance with governmental and regulatory requirements. + Implement utilization review and quality improvement ... + As a member of the largest non-profit health system in the US and the world's largest Catholic...in the US and the world's largest Catholic health system , Ascension St. Vincent Indianapolis serves the greater Indianapolis… more
- Lebanon Utilities (Lebanon, IN)
- …have met all applicable training requirements. Perform personnel audits to ensure regulatory compliance . + Maintain a safe utility workplace under utility ... to provide our community with reliable, economical and high quality services in a friendly and courteous manner. What...job descriptions and recommend appropriate pay ranges. + Ensure compliance with all applicable State and Federal human resource… more