- Kelly Services (Wilson, NC)
- …the Nurse Practitioner/Physician's Assistant (Sub Investigator) upholds the integrity and quality of clinical trials by ensuring all activities comply with federal, ... out in accordance with established research protocol and standards in compliance with all applicable laws, regulations, policies, and procedural requirements. +… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …regulatory affairs related to the development of novel therapeutics including quality , preclinical and clinical areas of drug development and the policies/procedures ... required to ensure compliance with regulations. **In this role, a typical day...if:** + If you bring good understanding of US FDA and international pharmaceutical guidance, regulations, drug development process,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …manufacturing sites. + Manage and maintain internal laboratory operations, ensuring compliance with 5S, Kaizen, and other continuous improvement methodologies. + ... regulatory submissions (eg, IND, NDA, BLA). + Support testing-related product quality investigations, CAPAs, and change control activities. + Communicate technical… more
- Insight Global (Maple Grove, MN)
- …team. This role involves ensuring that our product designs meet rigorous quality and safety standards throughout the development process. You'll collaborate closely ... technical files. . Drive the creation of test protocols and reports, ensuring compliance with regulatory and industry standards. . Analyze testing data and prepare… more
- Montana State University (Bozeman, MT)
- …+ Properly follows sanitation guidelines and handles food in accordance with FDA food codes and as directed by MSU's Registered Sanitarian. Ensures sanitation ... arts and exercise critically good judgment concerning taste and aesthetics of food quality + Work effectively and efficiently in close cooperation with CS staff in… more
- Community Health Systems (Franklin, TN)
- …and data-driven decision-making. + Partners with executive leaders across quality , safety, finance, operations, nursing, and informatics to translate complex ... learning, generative AI, and reinforcement learning where appropriate. + Ensures compliance with federal and state regulations regarding data privacy, security, and… more
- West Pharmaceutical Services (Tempe, AZ)
- …sensitive issues and handling sensitive confidential data to meet data privacy compliance requirements. + Experience with cases management system to record accurate ... and timely case updates for management information purposes. + Producing high quality documentation including reports, letters, meeting notes, etc. + Work with… more
- Grifols Shared Services North America, Inc (Greenwood, SC)
- …communication with other service areas to ensure accurate documentation and quality . * Completes all necessary documentation. Ensures donor confidentiality. Builds ... to support long- term donation. * Learns and maintains through familiarity and compliance with all state and federal regulations, US Food and Drug Administration (… more
- Danaher Corporation (New York, NY)
- …you also possess previous experience in: + Medical device product development + Regulated Quality Management System - eg FDA CFR 820, EU ISO-13485 Beckman ... Business System Office). + Ensure successful kaizen events by installing and ensuring compliance with the kaizen process (includes; (1) planning of kaizens with a… more
- Grifols Shared Services North America, Inc (Greenville, SC)
- …to support long-term donation. * Learns and maintains thorough familiarity and compliance with all state and federal regulations, FDA -approved Standard Operating ... guidelines. * Monitors donor and equipment to ensure health of donors and quality of product. * Sets up, disconnects and operates the automated plasmapheresis… more