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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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A core expectation of this role is a proven ability to excel and navigate change in a complex regulatory environment within the new and exciting Cell Therapy industry. Represent department as SME during regulatory audits as needed.
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Supports aspects of process technology transfer, process validation and the preparation of CMC documentation for regulatory filings and responses for the BMS Devens commercial manufacturing facility through cross-functional leadership and individual technical contribution.
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Experience with DeltaV and asset management system such as Maximo is preferred. But working at Bristol Myers Squibb is anything but usual. Experience within the Biotech / Cell Therapy space is preferred.
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Knowledge and experience with regulatory agency requirements such as NFPA, ASME [U] and [R] codes. Accountable for ensuring all quality & regulatory requirements are met. The Welding Supervisor is primarily responsible for overseeing and leading a team of direct labor associates in the manufacture and assembly of products, components and parts for custom equipment & structural items.
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Overseeing and supporting the Assistant Program Director in the implementation of program specifications per contract, regulatory requirements, licensing requirements, credentialing requirements, HIPAA, and/or other laws and regulations related to service delivery.
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As a Subassemblies Specialist, you will be the last set of hands and eyes on critical parts; as such, meticulous attention to detail in build quality is necessary. The Subassemblies team is responsible for delivering precision, ultra high vacuum subassemblies for seven major teams that go into the SPARC Tokamak.
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Manage all document control for Epic and keep up to date for regulatory compliance. They should have a clear understanding of regulatory compliance and be skilled in understanding scientific and technical data.
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Johnson Controls has an exciting opportunity for a Senior PCB Layout Designer!
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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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Guide Product Engineering through internal quality systems to ensure compliance with FDA, ISO, and other regulatory bodies. Author technical assessments and participate in Health Hazard Evaluations, including discussions with medical professionals and regulatory agencies.
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From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access.
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Directs all responses to customer complaints to the consumer affairs group. Maintains a superior-rated level of GMPs and sanitation, prepared for regulatory/customer inspections at any time.
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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.
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May clean and sanitize workstations and equipment and must follow all Sodexo, client, and regulatory rules and procedures. NOW HIRING IMMEDIATELY for a Grill Attendant in Leominster, MA. Observe and test foods being cooked by tasting, smelling, and piercing.
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regulatory affairs jobs Title: regulatory affairs specialist Company: Amgen in Groton, MA
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