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@keiyanahamlet
Driven Senior Analyst with expertise in microbiology and FinTech.
I am a driven Senior Analyst with over 6 years of experience in microbiology and financial technology. My expertise lies in FDA/cGMP compliance, data-driven quality control, and FinTech integration. I excel at bridging lab operations with financial systems to optimize drug safety, reduce costs, and streamline regulatory processes.
My technical skills include Python and SQL analytics, which I combine with hands-on sterility testing expertise to deliver actionable insights for senior leadership. I have successfully automated environmental monitoring data trending, significantly reducing manual analysis time by 30%. Additionally, I contributed to $500K in cost savings by revising microbiological SOPs and implementing corrective actions.
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Work history, roles, and key accomplishments
Fujifilm Diosynth Biotechnologies
Apr 2022 - Present (3 years 7 months)
Performed microbiological validations for finished products, in-process controls, and buffers per cGMP. Served as subject-matter expert for utility/environmental/material monitoring streams and automated EM data trending with Python, reducing manual analysis time by 30%.
Glennark Pharmaceuticals
Mar 2021 - Apr 2022 (1 year 1 month)
Performed sterility testing, growth promotion, and biological indicator testing per USP. Entered test results into LIMS and maintained real-time sample logs for audit readiness. Sampled critical utilities (WFI, Clean Compressed Air) and trended data for proactive risk mitigation.
Nephron Pharmaceuticals
Nov 2018 - Mar 2021 (2 years 4 months)
Conducted bioburden, environmental monitoring, and media fill tests following cGMP. Performed data entry and analysis for trending reports, ensuring compliance with specifications.
Nephron Pharmaceuticals
Oct 2017 - Nov 2018 (1 year 1 month)
Collected and analyzed air/water quality data, troubleshooting excursions and NCRs. Digitized manual logs into a SQL database, improving traceability by 50%.
Octapharma Plasma
Jul 2016 - Jul 2017 (1 year)
Ensured sterile plasma collection and compliance with federal transportation regulations. Maintained accurate records and followed strict protocols for biological material handling.
Degrees, certifications, and relevant coursework
Masters in Business Administration, Health Management Systems
Pursuing a Masters in Business Administration with an emphasis in Health Management Systems at Grand Canyon University. Expected to graduate between June 2025 and May 2027.
Bachelor of Science, Molecular Biology
Studied Molecular Biology at Winston Salem State University. Gained foundational knowledge in biological sciences relevant to microbiology and laboratory practices.
Certification, Financial Technology
Completed a Financial Technology Certification at UNC Charlotte. Focused on key FinTech areas including Python, APIs, and Blockchain.
Software and tools used professionally
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