Author Jobs in Fishers (IN)
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Search Results - Author Jobs in Fishers (IN)
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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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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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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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)-
Plan, Gap Assessment, Process Flow Diagram, Summary Reports and Process FMEA
• Represents TSMS in project teams and communicates directly with customers. Recognized as Subject Matter Expert for the manufacturing processes
• Author GMP manufacturing...
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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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Lead Candidate-Fishers (IN)-
equipment platforms, and digital transformation initiatives
• Author and review complex technical documents including risk assessments, CMC documentation, process validation protocols, CPV plans, and strategic technical reports
• Serve as senior technical...
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Lead Candidate-Fishers (IN)-
against approved specifications and artwork prior to use in label/pack operations
• Author, review, and revise SOPs, Work Instructions, and other GMP-controlled documents related to labeling operations
• Serve as a QA subject matter expert (SME)...
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Lead Candidate-Fishers (IN)-
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 and investigations...
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Yoh, A Day & Zimmermann Company-Noblesville, 7 mi from Fishers (IN)-
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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