Irene Nicole Nova
Quality Assurance Manager at Химия и Технология- Claim this Profile
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Russian Native or bilingual proficiency
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English Full professional proficiency
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French Limited working proficiency
Topline Score
Bio
Experience
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Химия и Технология
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Chemical Manufacturing
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1 - 100 Employee
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Quality Assurance Manager
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Aug 2013 - Present
Responsibilities: QC/QA Chemist in high purity solvent and consumer product manufacturing environment; ensured the smooth operation of all lab functions and production distillation/purification processes. Trained lab staff on test methods, instrumentation and production processes. Coached production staff on blending methods and hazardous waste management. Coordinated the investigations and closures of Non-Conformance Reports and issued corrective actions. Supported purchasing with supplier development and evaluation.Reviewed batch records, operational log books to ensure compliance to standard procedures and specifications. Maintained and reported on the company’s quality system.Planned manufacturing schedule. Streamlined production processes into the manufacturing software. Lead Scientific Research and Experimental Development projects. Prepared annual SR&ED tax refund reports. Utilized SPC techniques to monitor lab equipment and production processes.
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Sanofi
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France
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Pharmaceutical Manufacturing
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700 & Above Employee
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QOImmunochemistry Technologist
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2012 - 2013
Coordinate and perform routine standard testing in accordance with existing SOPs (e.g. ELISAs, Neutralization assays, identity tests). Responsible for the timely and accurate completion and verification of test related documents to ensure on time delivery of test results. (e.g. worksheets, log books, NuGenesis templates, test requisitions, verification of calculations and document entries for accuracy.) Ensure compliance is maintained in all daily activities by following SOPs, protocols and procedures as they apply. Responsible for writing protocols and reports for test transfers and method validations. Execute tests including parallel testing and/or experiments. Compile data and perform preliminary statistical analysis and troubleshoot if required. Update all relevant documents as required, implement changes (e.g. SOP changes). Participate in special projects, experiments or assays as required for existing products and new products. Training/skills upgrade/literature review to stay current with new technology.
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QA/QC Lead
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Aug 2001 - Jul 2012
Responsibilities: QC/QA Chemist in high purity solvent and consumer product manufacturing environment; ensured the smooth operation of all lab functions and production distillation/purification processes. Trained lab staff on test methods, instrumentation and production processes. Coached production staff on blending methods and hazardous waste management. Coordinated the investigations and closures of Non-Conformance Reports and issued corrective actions. Supported purchasing with supplier development and evaluation.Reviewed batch records, operational log books to ensure compliance to standard procedures and specifications. Maintained and reported on the company’s quality system.Planned manufacturing schedule. Streamlined production processes into the “SAGE” manufacturing software. Lead Scientific Research and Experimental Development projects. Prepared annual SR&ED tax refund reports. Utilized SPC techniques to monitor lab equipment and production processes.
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Junior Scientist
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Sep 1990 - Mar 1995
Planned, managed and performed field and lab research in accordance with projects;Controlled, coordinated and conducted research expeditions; Prepared histological samples of collected field material; Analyzed new data; experimental re-creation of the life cycles in the lab environment, summarized results; Planned, managed and performed field and lab research in accordance with projects;Controlled, coordinated and conducted research expeditions; Prepared histological samples of collected field material; Analyzed new data; experimental re-creation of the life cycles in the lab environment, summarized results;
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Education
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Institute of Zoology Academy of Science of Kazakhstan
Master of Science (MSc), Parasitology -
Karaganda State University
Bachelor of Science (BSc)/Master of Science (MSc), Biology, Chemistry