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Online Resumes with "Regulatory Standards"
Administrator - 15 Years of Experience - Near 17603
QUALIFICATIONS OVERVIEW Managing Multiple Programs Program Development and Evaluation Behavioral Health/Addiction Services Knowledge of Regulatory Standards Inspections and Surveys CQI and other Program Assessment Tools Treatment Facility Management Regulatory Standards DDAP, ACA, CARF, DOC, Behavioral Health Training Facilitator Managed 70+ staffs including Program Directors Responsible for all aspect of program operations...
Tags for this Online Resume: Training, Behavioral Health, Facilitator, Licensing, Blue Prints, Blueprints, Purchasing, Services, Food Service, Quality Assurance
Life Scientist - 8 Years of Experience - Near 27617
Summary Ph.D in Pharmaceutics with extensive experience in analytical method development, method transfer and validation for Small and Large molecular API, in a GMP environment. Specialized in mass spectrometry/LC-MS method development and troubleshooting. Good knowledge of the GMP, GLP, SOP practices, the USP, EP, NF, FDA and ICH guidelines. Proven problem solver, motivated team leader and excellent communicator Qualificat...
Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), ELISA, protein, Protocol, LC-MS, MASS, API, Process Improvement, Application Program Interface, FORMULATION, QC, ANALYTICAL, pharmaceutics
Clinical Research - 8 Years of Experience - Near 60169
Professional Summary A certified professional Clinical Research with 4 years of experience in Clinical Research coordination and a year experience as Clinical Study Associate. Expertise in QC of documents, remote Monitoring and supporting the management by handling the tasks of multiple clinical research studies managing eTMF's & designing Clinical Portfolio's from Sponsor end. Expert in liaising between different departmen...
Tags for this Online Resume: Document Management, Monitoring - Remote and onsite, Clinical Research coordinator, Device trials, clinical Research, Project Management, QC and QA, Pharmacovigilance, Ethics and compliance, regulatory, Clinical study Associate, Multiple therapeutic areas experience, Phase 1-4 trials, Audits and Inspection readiness, Multiple software and application experience - Veeva VAULT , Impact , Quest , Sentinel,Tesla, EDC experience- RAVE Medidata, IRT system experience Clinpace , Endpoint
Director
SUMMARY OF QUALIFICATION * Extensive experience in FDA regulatory requirements (GMP, CFR) and ISO standard regarding Medical Device, Pharmaceutical, Skin Care, and Food Industry * Extensive experience Lean Quality Tools (FMEA, Pareto Charts, Fishbone Diagrams, Six Sigma 5S, and SPC to assure efficient process and high product quality product * Extensive experience in managing the Supplier/ Vendor qualification program, Supp...
Tags for this Online Resume: Extensive experience in CAPA, Extensive experience in IQ/OQ/PQ VAlidation, Extensive experience Quality audit, Extensive experience Supplier Qualification, Extensive experience FDA and ISO Regulatory, Extensive experience Process and Quality improvement, Extensive experience Reducing customer complaint, Scheduling, Chemistry, Good Manufacturing Practices
Clinical Research - 20 Years of Experience - Near 20882
Summary: Over 16 years managing clinical trials and data collection activities. Manage as Point of contact for sponsors, project teams, and investigational sites to facilitate clinical studies Phase I-IV. Responsible for the review and approval of case report forms, electronic data capture systems, review of protocols, implementing study procedure manuals, and monitoring plans. Additionally manage site selection, study exec...
Tags for this Online Resume: Collection, Quality Assurance, Test, Process Improvement, Project Management, Project Manager, Business Requirements, Clinical Research, Data Entry, Filing
Dietician or Nutritionist - 1 Years of Experience - Near 06082
Accomplishments * Executed full patient assessments forms and protocol, including tube feeding and TPN. * Developed charting accuracy through precise documentation. * Collaborated with physicians to plan and implement patient care. * Delivered compassionate care that exceeded hospital requirements. * Successfully provided quality care to patients in acute care as well as out-patients. * Maintained compliance with regulatory...
Tags for this Online Resume: Compliance, Health Insurance Portability And Accountability Act, HIPAA compliance, Patient Education, Acute Care, Assessments, Chemotherapy, Documentation, Inventory, ServSafe Certified, Hartford/Springfield area, Registered Dietitian
Chemical Process Engineer - 10 Years of Experience
PROFESSIONAL SUMMARY Chemical Engineer with 9 years of experiences in process design engineering, engineering procurement and project coordination for various metal, refinery, petrochemical, cement companies & Water treatment plants. Projects include grassroots complexes, plant revamps, debottlenecking and expansions, auxiliary facilities and technical services.
Ideal Companies: 1. Bechtel Group, Inc, 2. Foster Wheeler Ltd :Amec Foster wheeler, , 3. Fluor Corporation, 4. KBR, Inc, 5. Jacobs Engineering Group Inc, 6. EMCOR Group, Inc, 7. CH2M HILL Companies, Ltd, 8. KP Engineering, LP, 9. URS Corporation, 10.Black & Veatch Holding Company, 11.WorleyParsons Corporation, 12.Burns & McDonnell, Inc, 1. Almatis INC, 2. Cemex Inc. | Houston., 3. Lafarge North America | Herndon, Va., 4. HeidelbergCement | Allentown, Pa., 5. Holcim Inc. | Dundee, Mich., 6. Vulcan Materials Co. | Birmingham, Ala., 7. Colas S.A. | Roseland, N.J., 8. Martin Marietta Materials | Raleigh, N.C., 9. MDU Resources | Bismarck, N.D., 10.Barrick Gold, , 11. Alcoa, , 12.Freeport-McMoran, , 13. Goldcorp
Tags for this Online Resume: • Chemical process engineering, • Engineering procurement & construction (EPC), • Process design in refinery, petrochemical, mineral processing & cement industry, • Project management, Project coordination, documentation & planning, • Chemical Unit Operation, • Front end engineering, • RFQ, Tender preparation, bid evaluation & vendor assessment, • Feasibility & detailed bankable report including project cost estimation, financial analysis etc., • Preparation and review of PFD, P&ID, DPTD, Line list, • Process calculation, Heat & mass balance, • Technical standard / procedure - technical work practice (TWP), • Review engineering for green and brown field projects, • Computer skill: Aspen Hysys, Auto CAD drawing, SPP&ID, Pipe flow, HTRI, Blueprint for requirement management, Microsoft Office (Word, Excel, PowerPoint), MS Projects, Lotus Notes, SharePoint, MS Visio, • Languages: Fluent in English, Bengali, and Hindi, chemical Engineer, Process Engineer
Safety Manager - 13 Years of Experience - Near 20748
Summary of Experience: Experience and certified accomplished safety manager with over 17 years proven track record of successfully managing multi contract, contractor and sub-contractor in engineering construction and infrastructure projects environment through all phases of development. Extensive experience including safety and quality oversight to ensure ISO 9000-2000 standard, safety compliance to 29 CFR 1910 and 1926, 4...
Tags for this Online Resume: ISO, Policies and Procedures, Management, Project Management, Transportation, Compliance, Construction, Documentation, Hazardous Waste, Infrastructure
Engineering Manager - 20 Years of Experience - Near 60089
Highly motivated professional with leadership experience across verticals in regulatory compliance responsibilities. Recognized for excellence in search and planning for applicable worldwide regulatory standards for NPI/NPD. Self-starter, versatile, problem solver, and have willingness to work as part of a team. Forward thinker with demonstrated ability to lead and manage multinational cross-functional teams, analyze comple...
Tags for this Online Resume: Test, Troubleshooting, UL, Test Plan, Video, Wireless, Compliance, Consumer Products, EMC, Leadership, Energy Efficiency Compliance, REACH, EMI, EMC, HIRF, Lightning, ESD, Electrical safety, UL, wireless, Test Plan, Control Plan
Manager - 20 Years of Experience - Near 30082
kirkdwilliams@outlook.com Partner for start-up company focused on creating a cost-effective alternative to contemporary media streaming services. Delivered a patent-pending platform that delivers simulcast content via any internet connected platform at a fraction of the cost of live streaming services. * Delivered patent-pending technology to deliver simulcast audio/video content without requiring multicast/streaming techno...
Tags for this Online Resume: Account Manager, Architect, Communications, Account Management, Management, Packaging, Infrastructure, Product Management, System Testing, Test, MySQL, AZURE, AWS, Architecture, Network, Wireless, Security, PHP, Javascript, .NET, Executive Briefings, SAP, TWS, SAN
Risk & Insurance Manager
(r-i.2) Summary Supervise, review and authorize Consultant's provision of Loss Prevention-Safety services. Survey/Audit development and implementation: Regulatory/Industry specific/Client's requested reviews. Provide specific Training designed to support pre-loss intervention and recovery/mitigation strategies addressing historic loss frequency/severity issues. Advise Clients of non-insurance options to reduce risk suscepti...
Tags for this Online Resume: ARM, Associate in Risk Management, Automation, Compliance, Insurance, Management, Audit, P&C, Team Player, Underwriting
General Manager - 10 Years of Experience - Near 44202
Qualifications Profile Highly organized, self-motivated, and results-driven professional, with extensive experience in operations management complemented with expertise in identifying profitable growth opportunities within fast-paced environments. Display expertise in leading cross-functional teams toward the attainment of organizational goals and initiatives. Possess broad knowledge of regulatory standards as well as Occup...
Tags for this Online Resume: Occupational Safety and Health Act, OSHA, Management, Logistics, Manufacturing, New Business Development, Account Manager, Fire Protection, Government
