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Coordinate/author/review drug substance relevant sections of regulatory documents (IND, IMPD, NDA and MAA) Qualified candidates must have a PhD in synthetic/organic chemistry or related scientific field with 15+ years’ experience in drug substance development and manufacturing and a proven track record in developing and scaling up chemical process to kilo lab, pilot plant and commercial plant scales.
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Perform other administrative documentation and record keeping, such as accountability and statistical reports, billing forms, student intern evaluations, performance evaluations, etc. Ensure clinical documentation is complete and according to departmental standards.
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Must have 2 years of experience performing testing and root cause analysis; developing code, APIs, pipelines; working with databases; maintaining technical documentation; using Microservices, NoSQL, Spring Boot, RESTful services, Cloud technologies, AWS, Java, Junit, Spring Security, Kafka, Angular, Jenkins, BitBucket, CI/CD, SQL, Python, Gradle, Maven, Jupiter.
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Primary Sterile Processing responsibilities include receiving instrumentation, sorting and decontamination of procedural items and instrumentation; inspection and assembly of minor instrument groups and instrument trays; identification of respective sterilization method and cycle selection, accurate documentation for all sterile processes; and accurate inventory assignment relating to the case building process.
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Understands, conducts, and documents appropriately Dialysis/Apheresis machine safety tests/alarm tests, equipment calibration, dialysate testing, machine safety tests, functional testing, and internal and external disinfection on all water & dialysis machines, and complies with the documentation/notification standards per FMS policies.
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This involves the development of a control system architecture, selecting the components to be used, detailing schematic diagrams and system documentation, programming controllers (PLC, DCS, RTU), programming the process visualization (HMI/SCADA), developing databases for archiving/displaying historical system data and implementing/commissioning the control system at the client’s facility.
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Participate in the development of electronic clinical data case report forms, author medical data review plan, review data integrity and trend, and contribute to study monitoring and data analysis.
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Maintain daily and monthly progress notes, shift checklists, and other program documentation according to DDS, DMH, and all applicable regulatory standards. Provide services to individuals according to, DDS, DMH, MassHealth, HUD, DPH, CARF, all applicable regulatory standards, and Bridgewell policies and procedures.
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RMF, NIST, and NISPOM requirements, configurations, settings, and documentation. Ensure that authorization/re-authorization support documentation is developed and maintained in conformance with applicable standards.
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Collaborate with patients families, friends, and social supports in care of patient Communicate well with CCRNs and Chronic Care Nurse Manager and escalate any concerns of patient safety as necessary Maintain accurate, timely documentation of case management activities in EHR, and internal documentation Assist with information gathering on medication compliance with team Engage members and caregivers in active care planning with a focus on medical, behavioral, social, member-centered care needs.
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Extensive knowledge in various business functions, enterprise, semiconductor manufacturing, engineering design and processesCommunication and collaboration with extended global teams, both within IT and outside IT.Additional Skills, Knowledge and AbilitiesStrong presentation and technical documentation skillsStrong organizational skills and the ability to work and lead a team to aggressive schedules.
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You'll also manage administrator accounts, maintain user directories and system documentation, and optimize system performance, specializing in Red Hat and Solaris Linux as well as VMware. Setup administrator and service accounts, maintain active directory of users and system documentation, and tune system performance.
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Follows CMOP policies regarding documentation and reports to meet VA and TJC policy. Provides full checking, labeling, and quality assurance within the guidance (written VHA handbooks, written CMOP policies, and training that will be provided by the CMOP) of the Department of Veterans Affairs regarding pharmaceutical medications.
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Ability to author site work plans, reports, and proposals for complex scopes of work. Remediation Expertise: Evaluate subsurface characteristics for soil, soil vapor, and groundwater remediation projects, and apply remedial systems and solutions.
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Develop and implement processes, tools and documentation for Transmission Planning & Asset Management to maintain compliance with ISO New England rules/policies, NPCC Criteria/Directories, NERC Standards, and FERC Orders.
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author documentation jobs in Bedford, MA
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