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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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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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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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Ensure quality control and quality assurance of product manufacture, fabrication, and repair consistent with the established ASIC Quality Standards and customer requirements.
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As the 2nd Shift QC Chemist, you will be responsible for carrying out sample preparations and sample analysis in compliance with CLIA/CAP standards and adhering to QA/QC requirements. Ensure compliance with all laboratory safety programs and CLIA/CAP requirements.
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Five years of experience in clinical setting analyzing data and performing reviews such as utilization management, quality assurance, charge capture, coding, billing and medical necessity to facilitate correct claims submission to federal and state payers required.
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Job Title: Director of Food Safety and Quality & SQF Practitioner Position Reports to: General Manager Backup Person: General Manager and Substitute SQF Practitioner FLSA Status: Exempt Section 2: Summary Reporting to the General Manager, the Director of Food Safety and Quality & SQF Practitioner is responsible for the execution of the Food Quality Control/Quality Assurance programs and processes and continuous quality improvement of our products and processes.
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Lead the response to quality or compliance issues, including product recalls, regulatory actions, and customer complaints, ensuring timely and transparent communication with all stakeholders.
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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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The Training and Quality Assurance Manager is responsible for ensuring compliance with all required portfolio training, as well as Allied Universal standards and reports directly to the CE Regional Training Director.
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Serve as a technical resource on air quality compliance assurance and permitting programs, including regulatory analyses of industrial facility operations; major and minor source air permit applications under NSR, PSD, Title V, and state-level regulations; and NESHAP MACT compliance programs.
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This position collaborates closely with cross-functional team members, including analytical development, quality assurance, manufacturing and process development, regulatory and clinical operations.
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Job Summary: The Sr. Regulatory & Compliance Specialist is responsible for assuring compliance with all food safety & regulatory matters, also for supporting the Sr. QA Manager in developing, implementing, and enforcing Food Safety Programs for the company (including SQF program), oversees the plant SQF program to ensure certification is maintained.
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Job SummaryThe 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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Ensure compliance with regulatory requirements, company policies (including GMP’s) and standard operating procedures (SOPs). Develop and partner with Sr. QA Manager on the implementation of Safe Quality Food (SQF) programs – including HACCP, Food Safety, Food Quality and Food Defense plans.
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quality assurance control regulatory compliance jobs Company: Intermountain Healthcare
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