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Expert level knowledge of regulatory validation requirements including FDA, EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8, and Q9) particularly as it applies to biologics / cell therapy manufacturing.
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Maintain required documentation according to DDS, DMH, MassHealth, HUD, DPH, CARF and all applicable regulatory standards as well as Bridgewell policies and procedures. Provide services to individuals according to DDS, DMH, MassHealth, HUD, DPH, CARF and all applicable regulatory standards, as well as Bridgewell policies and procedures.
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Provide significant regulatory inspection readiness training, coaching and guidance to junior level staff/SMEs in validation group. Experience interacting with regulatory agents, external and/or internal auditors in a compliance audit environment with direct interaction including face to face interaction and response to audit questions.
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Regulatory Compliance: Lead preparations for regulatory inspections and audits, complete the annual DPH survey, and ensure the facility’s long-term care license remains in good standing.
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Highly knowledgeable of regulatory validation requirements including FDA, EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8, and Q9) particularly as it applies to biologics / cell therapy manufacturing.
Full-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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Work cross-functionally across technical operations and with the external CMO's and technical teams leveraging other functions within BMS such as process and analytical development, quality, regulatory, manufacturing and supply chain counterparts.
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Intertek, a Nationally Recognized Testing Lab (NRTL) and leading provider of ATIC (Assurance, Testing, Inspection, and Certification) Services to many of the world's leading brands and companies, is actively seeking a Project Engineer - Cybersecurity, Medical to join our Electrical team in Boxborough, MA. This is a fantastic opportunity to grow a versatile career in facilitating international trade and regulatory product testing on the Electrical Team.
Full-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
$39.15 an hourFull-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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Familiarity and experience with systems such as BMRAM (Blue Mountain Regulatory Asset Management), Elemental Machines, MAXIMO, Siemens BAS is beneficial. Knowledge of IMTE (Inspection, Measurement, and Test Equipment), General understanding of control systems including PLCs, HMIs, Building Automation Systems, CCMS (Computerized Calibration Management Systems.
Full-timeExpandApply NowActive JobUpdated 28 days ago - UpvoteDownvoteShare Job
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Adhere to all state and federal regulations, if applicable, as set forth by the US Department of Transportation (DOT), Occupational Safety and Health Administration (OSHA), Mine Safety and Health Administration (MSHA), or any other regulatory agency.
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As Quality Technician, you will be responsible for accurate performance and communication of all laboratory tests to determine wheat/flour quality and verify finished product meets customer, regulatory and Ardent Mills requirements.
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This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). We assist companies and non-profit organizations in delivering benefits to their employees.
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Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations- Reviews and approves Quality, Quality Control, Validation and Automation related documents- Review and approves Standard Operating Procedures (SOPs.
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Develop metrics and analytics of information security risks relative to regulatory guidelines, internal policies, and internal risk appetite thresholds. Oversee the completion of the ACET, Information Security/GLBA, New Products & Services, PMO, and the Governance Risk & Compliance Risk Assessments.
Full-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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Oversees a portfolio of diverse environmental projects with varied local, state (MA/CT/NH/VT/ME/RI) and federal regulatory drivers (i.e. MCP, Brownfields, RCRA, and Superfund). Prepares regulatory strategies for client advocacy and in anticipation of regulatory submittals and negotiations.
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regulatory job Company: Abbott in Groton, MA
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