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Author reports and prepare supplemental documentation to support the permit of electrochemical energy storage systems, including technical analysis of large-scale fire test data to justify the adequacy of the design of building MEP systems.
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In addition, the Software Test Engineer will work with System Engineers, Developers and other Testers to accurately author the test based documentation required for the project. Author and execute manual and automated test cases to ensure product requirements are met.
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The activities would include but not limited to CMO oversite, hands-on documentation review, contribute to deviations, investigations and CAPAs, provide guidance on product extended characterization and comparability assessments, author and review relevant CMC submissions.
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Author and develop SOP and VMP for computer system validation for manufacturing equipment. Author URS, FRS, Risk Assessments, Configuration specification, design specification and CSV test protocols and execute them in compliance with GDP guidelines and internal quality standards.
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Author, revise, & review data management related plans & documentation, including Data Management Plan, Data Review Plan, Electronic Case Report Form (eCRF), & completion Guidelines. Utilize reporting & data visualization tools such as Spotfire, J-Review, Business Objects &/or SAS to generate data review listings, also, project management tools such as Microsoft Project, Smartsheet or equivalent.
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This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. The Senior Biostatistician will provide statistical design expertise and data analyses for data derived from a multi-cohort consortia and will participate as a co-author in preparation of manuscripts and presentations reporting study results based on his/her analyses.
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Participate in generation, review and approvals of method qualification/validation protocols, executed protocols and reports in collaboration with Analytical Development; Author and/or review and approve QC Test Methods, SOPs, Work Instructions and all other documentation required in accordance with quality requirements.
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Author and maintain tools, techniques, and practices for assuring the testing of the product. Write testing documentation and help finalize all system and software documentation CDRLs for the program.
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Experience in the areas of Design Documentation (URS, FRS, CS, DS, and other engineering specifications) and Validation (OQ, CSV, etc.) Draft and implement Quality System documentation designed to establish good validation practices within the organization.
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Provide input on user and/or functional requirements of current and future processing equipment, and draft appropriate documentation. Execute assigned duties on time and pro-actively telegraph delays and other issues to validation manager and other relevant stakeholders.
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Drive failure analysis to understand root-cause and implement corrective actions- Author evaluation plans, technical documentation such as Engineering Requirements Specification (ERS), and aid in bring-up to deliver scalable solution to support Apple mass production in a high quality way- Collaborate closely with multi-functional partners (FW, Algorithm), including problem solving and requirement drafting across various functions and disciplines.
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Author instructional documentation that complies with the Toro Style Guide for Instructional Documentation. Create graphic line art, animations, and videos to enhance the overall communication effectiveness of the instructional documentation for Toro products.
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Create graphics that comply with the Toro Style Guide for Graphic Documentation. As a Technical Writer you will research, write, and electronically produce instructional documentation such as operator's manuals, installation instructions, and setup instructions.
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Author, review and may approve GMP-critical documentation, such as experimental reports, batch records, process work instructions, development and technology transfer reports. Area of responsibility 3: [Develop process engineering documentation and support GMP manufacturing.
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Works cross-functionally to author CMC regulatory documents and documentation in support of Amgens regulatory filings. Provides significant contributions to drug substance development teams (e.g., product, process development and product quality teams) by providing drug substance updates, documentation, data interpretation, technical recommendations, etc.
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