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This involves the development of a control system architecture, selecting the components to be used, detailing schematic diagrams and system documentation, programming controllers (PLC, DCS, RTU), programming the process visualization (HMI/SCADA), developing databases for archiving/displaying historical system data and implementing/commissioning the control system at the client's facility.
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Minimum 12 years' experience in payer or provider or integrated delivery organization with track record of leading complex data and technology integration work including a minimum 3-5 years of experience in data governance or data quality management with experience in data management and data technology and implementation of complex data solutions, ideally within the healthcare industry, ideally with a focus on value-based care models.
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Conducts investigations, collects data, analyzes trends and prepares reports for assigned quality processes. Use data generated from MRB to drive improvements to the manufacturing and quality system process.
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The selected candidate will also work collaboratively with Quality Assurance to assess laboratory conformance with cGMPs, and with CMC Regulatory Affairs to ensure the translational accuracy and integrity of data incorporated into Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities.
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Ensure compliance regulatory compliance with respective contract and model fidelity in conjunction with program leadership and Quality Assurance Team and VP of Homeless Services including State and Federal outcomes reports, third party billing, and HMIS data collection and reporting.
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Establish robust data governance processes and standards to ensure the quality, integrity, and security of clinical trial data. Proficiency in statistical programming languages (e.g., SAS, R) and clinical data management systems (e.g., Medidata Rave, Oracle Clinical) is essential.
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This role will collaborate closely with key cross-functional internal stakeholders including Clinical Operations, Medical Monitoring, Data Management, Supply Chain, and Clinical Compliance and Quality as well as external CRO and vendor partners to ensure quality study oversight from study start up through close out.
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ElevateBio is looking for a Cell Therapy Manager, QA Operations to join their growing Quality Group at our BaseCamp facility in Waltham, MA. In this role, the Manager will be primarily responsible for providing Quality oversight over execution of clinical cell and gene therapy manufacturing for cGMP compliance through on the production floor interactions, review and approval of batch related documents, and events.
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Incorporate core data management competencies including data governance, data security and data quality. Knoledge in Databricks, PowerBI, programing languages including SQL, Python and PySpark, data principles including data pipeline, streaming data, data storage, ETL, data integration, database design Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change.
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To assure the highest quality of services to the people in our day habilitation programs. He/she must demonstrate excellent verbal/written communication with a proven ability and familiarity with various data applications (Crossroads, Microsoft, HCSIS,) and possess the ability to work in an energetic, creative and positive manner with others.
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Support the performance of the other appropriate Quality Assurance functions including document writing/revisions, deviations, CAPA's, document/data review and other administrative duties as needed.
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Weekly Pay Range - $2790 To $3099 Summary : The Echo Tech produces quality images of heart muscle and functions; Sets up ultrasound equipment; records cardiac data and measurements using high frequency sound waves (ultrasound), and other noninvasive echocardiography testing equipment.
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Complete audits to assess accuracy and quality of scientific data submitted to the regulatory agencies in support of in vivo medical devices and in vitro diagnostic devices' application.
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Essential Experience & Job Requirements 5+ years of IT experience with major focus on data warehouse/database related projects Must have exposure to technologies such as dbt, Apache Airflow, Snowflake.
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Track, analyze, and report on internal programming requests and clinical programming key performance indicators, metrics, and program level deliverables and timelines Drive the development of Data Visualization tools providing information about data quality, study metrics, etc.
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data quality jobs Title: data specialist Company: Appleone in Bedford, MA
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