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@margaritavulfova
Experienced supplier quality specialist driving regulatory compliance and supplier performance improvements.
United StatesI am a results-driven Quality Assurance professional with extensive experience in supplier qualification, audits, and regulatory compliance within the pharmaceutical and medical device industries.
I have managed quality systems aligned with medical device and pharmaceutical regulations, led CAPA, change control, complaints handling, batch review and release, and risk management activities including FMEA.
My background includes performing external supplier audits, hosting customer and regulatory inspections, authoring annual product reviews, and harmonizing global quality policies to ensure consistent compliance and product quality.
I excel at cross-functional communication, root-cause analysis, continuous improvement, and implementing robust quality control systems that strengthen supplier relationships and deliver measurable quality outcomes.
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Work history, roles, and key accomplishments
RegenLab
Jan 2025 - Present (10 months)
Manage the Quality System per medical device regulations, driving CAPA, change control, complaints, audits and risk management including FMEA and batch review to ensure compliant product release.
Lohmann Therapy Systems LTS Corp.
Nov 2018 - Jan 2025 (6 years 2 months)
Maintained supplier qualification system, performed external supplier audits, authored annual product reviews, managed QA agreements and supported regulatory and customer audits to ensure supplier compliance.
Alcami Corporation
Apr 2017 - Nov 2018 (1 year 7 months)
Reviewed and approved laboratory investigations, deviations, CAPAs, change controls and validation protocols; supported regulatory compliance and FDA inspections through audit facilitation and documentation control.
Epic Pharmaceuticals
Oct 2010 - Apr 2017 (6 years 6 months)
Reviewed and approved production batch records, validation batches and certificates of conformance, coordinated product release and led investigations, root cause analysis and CAPA to ensure cGMP compliance.
Epic Pharmaceuticals
Oct 2008 - Oct 2010 (2 years)
Performed QC testing for solid oral and topical products including stability, assay, related substances and dissolution using HPLC, UV, IR and Karl Fischer, ensuring SOP and cGMP compliance.
Degrees, certifications, and relevant coursework
NUBachelor of Arts, Chemistry
Bachelor of Arts in Chemistry completed at New York University, focusing on chemistry fundamentals and laboratory techniques.
Software and tools used professionally
United StatesYou can contact Margarita and 90k+ other talented remote workers on Himalayas.
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