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Establish and maintain a Cell Therapy Quality Management System (QMS) to ensure compliance with regulatory requirements (e.g., FDA, EMA, etc.) 15+ years of experience in quality assurance and quality control within the biopharmaceutical or cell therapy industry.
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Oversee the KYC Quality Program ensuring that errors and observations from Quality Control (QC), Quality Assurance (QA), Compliance Monitoring & Testing, Internal Audit and Regulators are accurate and remediated in a timely fashion.
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As a key member of the Quality Assurance and Regulatory Compliance team, this role will support the regulatory needs of Dana-Farber's new inpatient cancer hospital and new collaboration with Beth Israel Deaconess Medical Center as that work ramps up.
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The Vice President, Quality & Controls Assurance reports to compliance leadership, and strategically and operationally leads various quality reviews of claims, Hierarchical Condition Categories (HCC) and clinical coding, call monitoring, system technology upgrades, and other critical compliance/financial/operational controls and processes across the CCA enterprise, including all health plan and care delivery activities.
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The Infusion Outpatient Pharmacist will work within the HHCI free standing oncology infusion center; overseeing the daily operations of the Compounded Sterile Products (CSP) area; assists in meeting regulatory compliance; and monitors training and competency assessment and quality assurance/control.
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The VP CMC Regulatory & Quality will lead all aspects of CMC Regulatory Affairs to support global regulatory submissions as well as CMC Quality Assurance and Quality Control for Invivyd’s clinical candidates and commercial products.
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Regulatory & Compliance Officer Responsible for assuring compliance with all food safety & regulatory matters, also for supporting the Director of Quality and Food Safety in developing, implementing, and enforcing Food Safety Programs for company including SQF program), oversees the plant SQF program to ensure certification is maintained.
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KEY REQUIREMENTS: Responsible for overseeing implementation of the company’s food safety and quality management system to assure food product integrity and compliance with specifications, SQF, GMP's, HACCP, USDA regulatory and customer standards.
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This position and is responsible for designing quality and control assurance reviews of claims, Hierarchical Condition Categories (HCC) and clinical coding, call monitoring, system technology upgrades, and other critical compliance/financial/operational controls and processes across the CCA enterprise, including all health plan and care delivery activities.
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Oversee and manage Quality Assurance including daily Quality Control Testing of finished drug, Facility maintenance and compliance, training, documentation and inventory control.
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Job Description Summary: Under the direct supervision of the Vice President of Educational Services, the Quality Assurance and Compliance Coordinator will administer the quality assurance and compliance processes, facilitate staff professional development and training, and implement a continuous quality improvement plan for all Educational Services programs.
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Develop, implement, and maintain Quality Assurance systems and processes to ensure compliance with regulatory requirements. On behalf or our client, 10X is seeking a Quality Assurance Manager responsible for overseeing all Quality activities related to managing licenses, Drug Enforcement Administration (DEA) compliance, and importing and exporting licensed drug and unlicensed drug products.
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Quality Control Supervisor opening in Vallejo CA. Looking for someone out of Food Manufacturing. Familiar in document control and help in developing and maintaining documentation such as SOP’s, as well as maintenance of manuals, policies and procedures as relate to any food safety and quality concerns.
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The Global Compliance Division's Regulatory Remediation Quality Control (RRQC) Team is responsible for reviewing the design and implementation of policies, procedures and controls to address regulatory expectations and remediation efforts.
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Develop, implement, oversee, and evaluate NHK’s Quality Department, including Quality Assurance and Quality Control (QA/QC), Formulations/Quotations, R&D, and Regulatory Affairs programs, policies, initiatives, goals and objectives.
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quality assurance control regulatory compliance jobs Company: Buckhead Meat Florida Division Of Buckhead Meat Co
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