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Document student progress toward meeting established objectives as stated in the individualized education program without interpreting the findings and report this information to the supervising speech-language pathologist.
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The Senior Clinical Document Specialist will provide support to the TMF content owners on one or more clinical programs. Familiarity with international clinical trials, clinical trial documents and document QC process highly desirable.
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As a QA Document Specialist II, you will play a pivotal role at Penumbra providing timely and accurate support of quality processes related to Document Services to ensure compliance with Penumbra procedures and regulatory requirements.
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We are looking for a Document Control Specialist who is highly motivated and passionate to manage quality system and product supporting documentation for novel Class III active implantable devices.
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Contribute to the development and maintenance of the data warehouse used to manage libraries of real-world evidence study data including image, source document and data files. Document data sources and data mapping.
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Minimum 4 years of experience in a regulated industry and/or experience in related operations areas such as manufacturing, materials management, quality control, quality engineering, document control, compliance, auditing, engineering and/or regulatory.
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Reporting and Document Management Maintain appropriate resident files including forms, leases, documents in accordance with FPI Standard Operating Procedures Responsible for the daily integrity and confidentiality of resident filesEnsure that documents and reporting systems are maintained, updated, and organizedMeet all periodic reporting requirements as requested/required e.g., Month End, Weekly Reports, Collection/Eviction Files etc.
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Support experience in S4HANA EWM, SMQ2 error handling, Document flow and inconsistencies, RF handheld device trouble shooting, Zebra and mobile printer issues resolution etc. Must have at least three full life cycles of SAP implementation experience in EWM area.
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Serve in a medical capacity on the company’s medical review committee (MRC) and Veeva document review platform, providing medical review, assuring accuracy of scientific and medical content and approval of materials in compliance within our corporate guidelines and governmental regulations.
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The Environmental Compliance Specialist is responsible for coding environmental commitments from environmental and permit approval documents into the Authority’s Environmental Management and Mitigation Assessment database application (EMMA), preparing reports in EMMA to identify gaps and document mitigation compliance, and supporting the Environmental Compliance Manager to use EMMA for construction compliance demonstration.
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He Senior Associate, Training and Document Management is responsible for Document Control and Training Coordination activities in the Quality Systems team at GeneFab while complying with company and regulatory requirements.
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Document the root causes of all machinery reliability issues in their area of responsibility and troubleshoot all problem rotating equipment to eliminate excessive maintenance cost and performance deficiencies and develop recommendations and orders required parts for upgrades of problem equipment.
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Engage with the SAP project team members as directed by the SAP Project Manager(s) to understand and document current and future state processes, support training and testing activities, and support organizational change related activities on the SAP S4 implementation.
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Observe, document, and communicate to the Care Manager or Director of Memory Care any physical, emotional, and mental changes in condition and/or all unusual observed resident behaviors (speech production, feeding patterns, toilet issues, etc.
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Monitor, document, and report suppliers’ performance and assist component engineer in compliance with regulatory and statutory requirements. Develop action plans and coordinates with QA Manager and cross-functional teams on bringing up the internal Systems to compliance with AS9100, ITAR requirements.
$80,000 - $130,000 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago
document job Title: implementation in Hayward, CA
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