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Interacting with clients, contractors, local government officials, you ll impact the whole project - from conceptual and design phases, through the regulatory review process, bidding, and construction, all the way to the grand opening.
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Understand and ensure compliance with safety and regulatory expectations. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities.
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Fosters and sustains a culture of continuous improvement practices, including leading a team of employees in the identification and implementation into quality systems/assurance, compliance, regulatory affairs and/or education and improvement activities.
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Ensures patient and team member safety and adherence to regulatory agency recommendations related to the sterile processing area. Requires one national certification (CRCST,CSPDT,CFER or CST) and a second national certification related to central service or sterile processing (Examples: CIS; CSIP; CFER; CST; CHMM; CHL.
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Provide consultation and interpretation of local procedures, corporate standards and regulatory expectations that apply to sample management. Provide oversight for sample management to ensure compliance for the handling of Special Security Substances (SSS) and controlled substances.
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Compliance and Quality Assurance: Ensure that all clean room construction activities comply with regulatory requirements and industry standards, including ISO cleanliness classifications and FDA cGMP guidelines.
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Knowledge of Data Historian (OSIPI) Knowledge of Computer System Validation lifecycle and FDA regulatory requirements. PACIV, an international control systems integration, and regulatory compliance engineering firm, servicing Bio-Pharmaceutical, Medical Device, F&B, and Utility clients, is looking for a regular employee-based Senior Automation Engineer team member to join our team based in the USA office (Indianapolis) Job Description : The Sr. Automation Engineer will be twofold.
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Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers.
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The Qualified Medication Aide sets up, administers, and records certain prescribed medications for residents in the facility under the supervision of a licensed nurse and as allowed by State regulatory agencies.
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Stay closely connected to platform users (aka Lilly software developers) via informal discussions, formal UX research, feedback tools, etc. As a Product Manager for this platform, you will be at the forefront of helping Lilly harness the power of LLMs and associated technologies to impact every aspect of our business.
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In partnership with the Safety & Training Manager, ensure that all team members have up-to-date training related to their work assignments, and ensure compliance in the basics of life safety, employee (team) safe practices, and compliance withOSHA,EPA,IDEM, and similar regulatory interties.
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Requirements: 8+ years of experience in Quality Assurance, with preference for medical device or related experienceBachelor's degree in Sciences, Engineering or another technical fieldDirect experience in manufacturingPerform as a coach / mentor to the team and others on staffStrong working knowledge of quality systems and regulatory compliance in medical devices, FDA and ISO standards.
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Maximus will comply with regulatory minimum wage rates and exempt salary thresholds in all instances. Work with Section 508 Compliance Tester to design and execute comprehensive accessibility web testing by using a broad range of tools, including but not limited to Web accessibility tool bar (WAT), Axe, FireEyes, JAWS, NVDA, WAVE, ZoomText, WindowEyes, Dragon Naturally Speaking, - Create accessible documents using standard software such as Adobe Professional, Microsoft Word, Microsoft Power Point, and Microsoft Excel.
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The Dietary Aide/Dishwasher is responsible for providing assistance with daily functions of the Dietary Department and to maintain a clean, safe work environment for all resident meals in accordance to the facility, OBRA, Federal State and other regulatory expectations.
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Comply with state regulatory standards related to Americans with Disabilities Act (ADA), Division of Disability and Rehabilitative Services (DDRS), Vocational Rehabilitation (VR), and Association of People Supporting Employment First (APSE.
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cmc regulatory jobs Company: Lilly in Indianapolis, Lexington, Massachusetts
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