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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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This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). Series 07 - FINRA, Series 63 - FINRA, Series 65 - FINRA, Series 66 - FINRA.
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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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Requirements: Master's degree in higher education/student affairs; diversity, equity and inclusion; or related field is required; Doctorate preferred. Serve on committees and working groups focused on diversity, equity and inclusion as requested, such as but not limited to the Committee for Diversity, Equity, Inclusion and Belonging and/or the Student Affairs Diversity, Equity, and Belonging Committee.
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Complies with health and safety requirements and with regulatory agencies such as DPH, etc. Opportunities with Reliant Medical Group, part of the Optum family of businesses. Join a team at the forefront of value-based care and discover the meaning behind Caring.
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Knowledge and experience with regulatory agency requirements such as NFPA, ASME [U] and [R] codes Organizing and planning work schedules Work order analysis & blueprint analysis to determine need for supplies and sequence of operations required Blue Print Reading& understanding assembly of sub components & building fixtures PREFERRED SKILLS: Two year degree, apprentice or secondary training in Weld Technology/Inspection Technology.
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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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10+ years of relevant experience in the pharmaceutical, biopharmaceutical or related industry Certification in lean manufacturing principles and Six Sigma toolsOperations experience in pharmaceutical manufacturing to cGMP standards including extensive knowledge of regulatory guidelines and validation practicesWorking knowledge of pharmaceutical development and commercialization processes.
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Providing general environmental compliance support to clients across a variety of regulatory program areas including hazardous waste, wastewater/storm water discharges, air emissions, chemical/spill prevention, and community right-to-know regulations.
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Provide scientifically rigorous statistical expertise on: Projects and protocols in support of clinical development and for publication, presentation, access negotiation, and other evidence generation efforts for Pfizer products; Regulatory and Health Technology Assessment (HTA) submissions; and projects to maximize the value of aggregate clinical and real world data in support of drug development and other scientific strategies.
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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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Analyze commercial lending / business banking related complaint activity by performing industry trend analysis and comparing to the credit union complaints to identify areas of risk, assessing escalated complaints and determining correct course for resolution, ensuring that regulatory complaints are closed within required time frames, and assisting with the creation of the quarterly draft reports for the Supervisory and Risk Management Committees.
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All positions must strive to support WFM core values and goals, promote national, regional, and store programs and initiatives, and ensure adherence to all applicable health and safety regulations including Food Safety and regulatory duties required in the department.
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General knowledge of land use planning/civil engineering principles and with Regulatory Agency/Municipal approval process. BJ’s pays weekly. Project involvement will range from Landlord reverse build-to-suits to full self-develop owned projects which may include surplus property for other retail uses.
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Organizational Skills - creative thinking, analyzing issues, decision making, collaboration Fluency with Microsoft Office and Excel with excellent writing skills Excellent communication skills, both written and verbal are required Ability to work independently and effectively collaborate with teams Hands-on experience in a laboratory setting and basic knowledge of chemistry is a benefit Familiarity with relevant quality, regulatory and ICH guidelines highly desirable.
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regulatory affairs jobs in Devens, MA
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