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Familiarity with regulatory requirements for bioprocess development and manufacturing (e.g., cGMP, FDA guidelines) The Capital Area Division (CAD) of Applied Research Associates, Inc. (ARA) is seeking a Synthetic Chemist / Chemical Engineer to design and develop continuous flow processes to produce various synthesized molecular products.
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The majority of the work is regulatory focused, therefore, our Senior Research Analysts also generate evidence for submission to federal regulators at the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), along with occasional interaction with other international regulators.
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Provide clear advice to Government Affairs and business clients on key federal and state laws, regulations, and policies, including the Inflation Reduction Act, Medicare and Medicaid laws, the Affordable Care Act, 340B, FDA regulations, OIG guidance, and others.
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Conducts all aspects of the donation process in compliance with established federal and state laws, OCME, AOPO and AATB standards, UNOS and FDA guidelines, CDC recommendations, AORN guidelines for aseptic technique and Infinite Legacy policies.
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The Research Coordinator will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations.
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He or she also will work closely with U.S. Attorneys' Offices and federal law enforcement partners, including the FDA, FBI,DEA, Postal Inspection Service, and Homeland Security Investigations. CPB works closely with U.S. Attorneys' Offices, the Criminal and Antitrust Divisions, and federal law enforcement agencies, including the FBI, DEA, Postal Inspection Service, and Defense Criminal Investigative Service.
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High school diploma or equivalent with three years or more meat and/or seafood industry (as appropriate) FSQA Leadership experience at a federal CFIA/FDA meat and/or seafood processing plant, or a Bachelor's degree in Animal Science, Food Science, or Biological Science from four-year college or university with one or more years meat and/or seafood industry (as appropriate) FSQA Leadership at a federal CFIA/FDA meat and/or seafood processing plant.
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The mammographer is required to be completely familiar with, and adhere to, all U.S. Food and Drug Administration (FDA) guidelines regulating the practice of mammography, radiation safety, and quality assurance requirements.
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Comply with state license laws, FDA guidelines, WSA and Total Care Plus practice guidelines and QPG protocols. Experience in a similar Audiology or Hearing Aid Specialist role. Perform hearing testing, hearing aid selection, and fitting to all clinic clients while working within the defined systems, processes, and best practices as defined by Total Care Plus (TCP) and WSA leadership.
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To support the Department of Health and Human Services (HHS), Food and Drug Administration (FDA). Founded in 2007, Initiate Government Solutions (IGS) a Woman Owned Small Business. We are a fully remote IT services provider that delivers innovative Enterprise IT and Health Services solutions across the federal sector.
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Working knowledge and understanding of QSR, ISO (13485), FDA and EU MDR and other medical device industry quality requirements. This will include DHR review, NCR and CAPA generation, processing, creation of quality records, risk assessment, ownership of all document control workflows, and support Management Review.
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Multiple stakeholder committees, registries steering committees, national working groups, and/or FDA advisory panel meetings. the regulatory and patient-safety work of FDA. He/she will direct the design, development, coordination, implementation, and.
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In addition, the Manager DC Warehouse II is responsible for Regulatory Compliance such as OSHA/FDA and others. Coca-Cola Consolidated, Inc. is an Equal Opportunity Employer. Initiates cross-functional collaboration by conducting a regular cadence of meetings and intentional interaction with business partners in Franchise Operations, Supply Chain Operations, Safety/Risk, Human Resources, Employee Relations, etc.
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IT support is provided via the IT Help Desk to FDA employees across six (6) regions in the United States: Mid-Atlantic, Northeast, Southeast, Southwest, Central, and Pacific. IT support is provided via the IT Help Desk to FDA employees across six (6) regions in the United States: Mid-Atlantic, Northeast, Southeast, Southwest, Central, and Pacific.
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One to 3 years of meat and/or seafood industry (as appropriate) experience at a federal CFIA/FDA meat and/or seafood processing plant (as appropriate). Formal job training in TQM principles, SPC, HACCP concepts, CFIA/FDA regulations would be beneficial.
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