Miracle Nwoye
Associate Manufacturing Scientist at SQI Diagnostics- Claim this Profile
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Bio
Credentials
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Occupational Health and Safety Act
Ontario worker health and Safety AwarenessMay, 2021- Nov, 2024 -
Workplace Hazardous Materials information System (WHMIS 2015 (GHS))
Workplace hazardous materials information system certificationMay, 2021- Nov, 2024 -
Ten Thousand Cofees Member
Ten Thousand CoffeesJan, 2021- Nov, 2024
Experience
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SQI Diagnostics
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Canada
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Biotechnology Research
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1 - 100 Employee
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Associate Manufacturing Scientist
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May 2021 - Present
• Executing and monitoring upstream manufacturing and post-processing activities in accordance with analytical test methods.• Preparing and reviewing product, process, and equipment documents including batch packaging records (BPRs), SOPs, logbooks, and all manufacturing records to meet precise GMP principles and internal standards.• Assessing of new analytical techniques and over 500 sample preparation.• Received commendation for successfully leading product scale-up and design change.• Collected and analyzed master bill of materials used in the research, manufacturing, and packaging of in vitro diagnostic test kits.• Creating and maintaining various historic data tables for project access.• Effectively trained and mentored 3 new interns and existing colleagues on upstream process, experimental assays, and preparation of different reagent according to cGMP and SOP requirements.• Develop and maintain forecast, manufacturing reagent schedule and procurement plan based on history and company priorities
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Quality Assurance Associate
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Jan 2018 - Jun 2019
• Conceptualized a process improvement to transfer training materials, BPRs, Logbooks and SOPs from a binder to a digital database using Excel & Word, improving data accessibility & accuracy, and cutting training time from ~2 months to 3-4 weeks.• Exhibited problem solving skills by performing ~30 quality assurance projects and batch reviews during 3 and 6-month intervals by collaborating with Quality Control and Manufacturing teams to develop accurate reports and ensure high batch quality.• Sorted and labeled 500+ samples to ensure safe organization and validated lab logbooks to follow SOPs.• Coordinated routine equipment maintenance and calibration of laboratory equipment, including LC-MS spectrometer, bioreactors, UV spectrophotometer and pH meter.• Evaluated raw materials and 500+ in-process and finished drugs according to quality assurance standards.• Wrote SOPs and trained new employees, leading a team of 3 within 3 months of hire date.
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Education
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2019 - 2020
University of Windsor
Master's degree, Medical biotechnology -
2013 - 2017
Afe Babalola University
Bachelor's degree, Biochemistry
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