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Knowledge of USDA, BRC, FDA and HACCP preferred. Summary The EHS Manager is a critical member of the Newly Weds Foods facility leadership team reporting to the Facility Manager with a strong dotted line to the Global Director of EHS.
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Oversight includes quality programs such as Quality Oncology Practice Initiative, Oncology Care Model, Commission on Cancer, FACT accreditation, FDA alignment, Vizient, and new accreditations to be pursued.
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The Associate/Assistant Toxicologist plays a key, hands on role in the conduct of preclinical studies and supports the Study Director to ensure that Sponsor studies are conducted properly and according to FDA guidelines.
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Facility EHS Manager SummaryThe EHS Manager is a critical member of the Newly Weds Foods facility leadership team reporting to the Facility Manager with a strong dotted line to the Global Director of EHS. Essential FunctionsLeads by example by living the Newly Weds Foods’ company values.
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Prior experience with CMC regulatory activities and/or agency (FDA) interactions in the development of advanced biologics is a plus. Work closely with Quality Assurance Specialist to ensure compliance with FDA and regulatory standards.
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Knowledge of the AMA, ACCME, PhRMA and FDA regulations associated with promotion and industry-supported scientific education activities. C-Suite roles (CEO, CFO, CBO), VP Finance, VP Clinical Ops, Specialty Pharmacy, Outreach Coordinator, Infusion Site Directors / Enrollers.
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Toxicologist plays a key, hands on role in the conduct of preclinical studies and supports the Study Director to ensure that Sponsor studies are conducted properly and according to FDA guidelines.
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Completes all activities by strictly following Good Clinical Practices (GCP) & all relevant current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU and Lurie Institutional Review Boards (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH.
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Function as the subject matter expert for the interpretation, application and compliance with regulatory and industry safety standards, including OSHA, CAP/CLIA, NYS, FDA, ISO, EPA, and DOT. Ensure compliance with all applicable regulatory safety standards in the laboratory departments, including cell culture, molecular, NGS, histology, biorepository, and nucleotide extraction laboratories across 3 sites.
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Must have 2 years of experience in at least one of the following regulatory compliance models: SOX, FDA, FERC/NERC, HIPAA. IT Risk Advisor, Technology Consulting - Governance Risk and Compliance Technology (SAP) (Manager) (Multiple Positions) (1493800), Ernst & Young U.S. LLP, Chicago, IL.
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Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
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Learn and maintain thorough familiarity and compliance with all state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP) and internal company procedures.
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Supervise donor selection, plasma collection and all manufacturing records to maintain the highest production standards in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and cGMP.
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Prior experience with CMC regulatory activities and/or agency (FDA) interactions in the development of advanced biologics. Prior experience with CMC regulatory activities and/or agency (FDA) interactions in the development of advanced biologics.
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KNOWLEDGE SKILLS & ABILITIES:Extensive knowledge of OSHA regulations, Joint Commission and HFAP and CMS COP standards, FDA and other applicable State and Federal rules and regulations. GENERAL SUMMARY/BASIC PURPOSE OF JOB:Reporting directly to the President of Mount Sinai Hospital Medical Center, the Vice President, Facility Operations, Design & Construction, and Real Estate develops and executes a system wide plan for Facilities Management which results in operational excellence, high customer and staff satisfaction, consistent and effective service delivery, and improved operating costs.
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fda job in Bedford Park, IL
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