Author Jobs in Indiana
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Search Results - Author Jobs in Indiana
Meet Life Sciences-Fishers (IN)-
and clients to translate complex technical data into user-friendly documents, ensuring alignment with regulatory standards and operational needs.
Responsibilities
• Author, review, and maintain technical documents such as Process Flow Diagrams, Summary...
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Butler Aerospace & Defense-West Lafayette (IN)-
conforming conditions on primary parts, assemblies and final product verifying disposition will meet blueprint requirements
• Author process plans for non-compliant structure via non-conformance reports (NCRs) instigated by manufacturing
• Review...
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Lead Candidate-Fishers (IN)-
monitoring data for viable and non-viable particulates from routine surveillance and EMPQ programs
• Author and maintain Environmental Monitoring Performance Qualification (EMPQ) reports in compliance with regulatory requirements
• Support environmental...
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Aegis Worldwide-Carmel (IN)-
on products, materials, and environmental samples
• Support environmental monitoring (EM) programs, including data trending and reporting
• Author, review, and update SOPs and related documentation
• Investigate OOS results, support root cause analysis...
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L3Harris Technologies-Fort Wayne-
and test engineering for the build and test of subsystems and payloads.
• Leadership of mechanical analysis teams for IR payloads and mechanical subsystems
• Strong communication skills for internal and external presentations and reviews
• Author mechanical...
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Lead Candidate-Fishers (IN)-
regulatory inspections, agency interactions, and client audits, and as senior technical advisor to key clients
• Evaluate, select, and implement new manufacturing technologies, equipment platforms, and digital transformation initiatives
• Author and review...
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Cognizant-Indianapolis-mindmatch.ai-
and excellence
Represent Cognizant at industry forums, author thought leadership, and contribute to IP development
Work Model
We believe hybrid work is the way forward as we strive to provide flexibility wherever possible. Based on this role’s business...
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Takeda Pharmaceutical-Cambridge-
topics, as applicable.
• Develop/author and execute global regulatory strategies for complex strategies. May oversee execution.
• Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan...
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Varsity Tutors, a Nerdy Company-West Lafayette (IN)-mindmatch.ai-
through analyzing participial phrases, constructing indirect statement, identifying subjunctive usage by clause type, and translating adapted Latin authors. Emphasizes developing reading fluency and connects intermediate Latin to Roman literature, legal...
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Takeda Pharmaceutical-Cambridge-
on product specific value evidence topics, as applicable.
• Develop/author and execute global regulatory strategies for complex strategies. May oversee execution.
• Monitor and anticipate trends that impact both the regulatory and access environments...
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L3Harris Technologies-Fort Wayne-
of subsystems and payloads.
• Leadership of thermal analysis teams for IR payloads and mechanical subsystems
• Strong communication skills for internal and external presentations and reviews
• Author thermal analysis sections of PDRs, CDRs, and other required...
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Takeda Pharmaceutical-Cambridge-
on product specific value evidence topics, as applicable.
• Develop/author and execute global regulatory strategies for complex strategies. May oversee execution.
• Monitor and anticipate trends that impact both the regulatory and access environments...
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Yoh, A Day & Zimmermann Company-Noblesville-
agencies and guidelines (i.e. FDA, DEA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
• Author, revise, review and approve site procedures and policies related to Environmental Monitoring and Sterility as applicable.
• Author quality control EM data trend...
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Lead Candidate-Fishers (IN)-
Matter Expert for manufacturing processes in project teams
• Author GMP manufacturing documentation including Master Batch Records, BOM, and Processing Forms
• Monitor process data, identifying trends and proposing actions
• Lead technical troubleshooting...
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Lead Candidate-Fishers (IN)-
that leverage facts and data to support robust root cause conclusions, effective corrective actions, and systematic all-encompassing preventative actions.
WHAT?
• Understand, investigate, and author a variety of deviating conditions or nonconforming events...
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