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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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Experience with solving steady state and dynamic thermal and mechanical problems, using finite element analysis (FEA) and computational fluid dynamics (CFD) software is a plus. Conceptual knowledge of process troubleshooting, failure analysis and Six Sigma methodologies (Process mapping, C&E, PFMEA, DOE, SPC.
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Ensures compliance within guidelines set forth by regulatory agencies (DPH, ERISA etc.) Demonstrates a knowledge and understanding of what to report to the CEO or Chief Compliance Officer when concerns of corporate compliance arise.
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Advise on, develop, and support regulatory compliance International Traffic in Arms Regulations (ITAR), Export Administration Regulations (EAR), Foreign Trade Regulations, Dept. of Defense (DoD), Office of Foreign Assets Controls (OFAC), EU Common Military List, and other import/export regulatory requirements and laws.
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Assists the project in work planning and development of job hazard analysis and safe work procedures Performs regular field safety inspections, accident/incident investigations (including root cause analysis), industrial hygiene assessments and safety audits on active construction projects.
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Assist with the management of bank documents, supporting bank due diligence requests, and all bank regulatory compliance requirements. Experience performing various treasury operations, cash management functions to include wires, ACHs, cash positioning, forecasting, investments, revolvers, knowledge of various bank file formats, ad-hoc analysis, bank balance reporting, bank fee analysis, and credit rating analysis.
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Actively support the preparation of CMC regulatory filings including methods, batch analysis, and stability sections. In addition, review and approve CTL assay development and validation reports, relevant sections of clinical documents pertaining to AAV and RNA analytical testing and documentation for submission to regulatory agencies.
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Drives functional performance that meets required standards and regulatory compliance. Minimum of 5 years’ experience in Product Stewardship or a related field such as Supplier Quality, R&D, operations, technical support, quality or regulatory.
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Perform all tasks in compliance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs) and other regulatory requirements. Combined with Charles River’s integrated, early-stage portfolio of discovery, safety assessment, and manufacturing support services, the acquisition creates a unique, comprehensive solution for researchers and cell therapy developers and manufacturers worldwide to help accelerate their critical programs from basic research and proof-of-concept to regulatory approval and commercialization.
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The Electrical Analysis - Northeast section of the Materials & Process Engineering Department is seeking an individual to fulfill the role of a Senior Electrical Failure Analysis Engineer.
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Our offerings include source testing for routine regulatory compliance, engineering studies, control device evaluations, MACT demonstrations, relative accuracy test audits (RATAs), and trial burns; ambient air monitoring; temporary continuous emissions monitoring systems (CEMS); and advanced testing capabilities in Fourier Transform Infrared Spectroscopy (FTIR) and gas chromatography.
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The position requires the ability to work through each step of an analysis, which may include external visual photo-documentation, electrical test, non-destructive troubleshooting, environmental testing, x-ray evaluation, destructive testing, decapsulation, cross-sections, internal visual photo-documentation, scanning electron microscope (SEM) evaluation, and writing a detailed final report.
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Analysis of silicone raw materials, intermediate formulation mixes and final formulations using various state-of-the-art analytical techniques including but not limited to GPC, HPLC, GC, rheometer, UV-vis and others.
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Factors that may be used to determine rate of pay include specific skills, work location, work experience and other individualized factors JOB SUMMARY Monitor Food Safety & Quality Assurance (FSQA) support/evaluation programs and inspection/audit procedures to ensure compliance of products and processes to corporate and regulatory requirements at a Sysco Specialty Meat and/or Seafood Company.
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Must have: A Bachelor of Science degree in Electrical/Control Engineering, Mechanical Engineering, Chemical Engineering, or Computer Science 10+ Years Work Experience Ignition & Rockwell Relevant regulatory requirements of the life science industry such as cGMP, 21 CFR Part 11, etc.
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regulatory compliance analysis jobs in Lowell, MA
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