Margarita Vulfova
Brooklyn,NY
Summary
- Experienced Quality Assurance professional with thorough knowledge of the essentials of safety and quality.
- Proficient in Quality and Regulatory regulations that govern the pharmaceutical industry.
Results-driven Supplier Quality Specialist known for high productivity and efficient task completion. Possess specialized skills in supplier audits, quality control systems implementation, and continuous improvement processes. Excel in communication, problem-solving, and adaptability, ensuring success in managing supplier relationships and improving product quality.
Overview
16
16
years of professional experience
Work History
Supplier Quality Specialist
Lohmann Therapy Systems LTS Corp.
West Caldwell, NJ
11.2018 - Current
- Maintenance of a robust Supplier Qualification System to ensure manufacturers/suppliers/distributors of materials are qualified and approved
- Performing external audits of suppliers to qualify new suppliers/service providers and re-qualify existing suppliers
- Hosting Regulatory Inspections
- Authoring of Annual Product Reviews
- Oversight of Harmonization with global company policies
- Oversight of Quality Assurance Agreements with contract givers and contract acceptors
- Prepare and issue certifications as required
- Hosting customer audits
- Demonstrate leadership skills by facilitating audit responses and holding meetings as needed for process improvement activities
Quality Assurance Specialist III
Alcami Corporation
Edison, N.J.
04.2017 - 11.2018
- Quality review and approval of Laboratory Investigations, Deviations, and CAPA's
- Review, approval, and initiation of Change Controls, ensuring all impact assessment to major systems is performed and documented
- Review and approval of Protocols and Reports associated with method validation, verification or transfer
- Review and approval of Certificates of Assurance of Quality, and all associated networks in Electronic Lab Notebook
- Review and Approval of Calibrations and Preventative Maintenance for all laboratory instrumentation; review of chamber, refrigerator, and incubator mapping and study
- Support Regulatory Compliance during internal audits and Client Audits- including review of pertinent documentations and procedures, and facilitation of audit responses and initiation of necessary CAPA's
- Support the Alcami Corporation during inspection by major regulatory agencies, including the most recently conducted F.D.A
- Inspection of March, 2018
Quality Assurance Associate
Epic Pharmaceuticals, LLC
Laurelton, NY
10.2010 - 04.2017
- Review, approval and compilation of Production Batch Records
- Review, approval of Validation Batches and Protocols, including site transfers and new submissions
- Ensuring accuracy of reports prepared after Protocol is complete
- Review and approval of Certificates of Conformance of Quality, Preparing Certificates of Assurance
- Coordination of timely release of finished product and in-process batches
- Investigation of Technical and Product Quality Complaints filed by customers, assuring a proper and timely response
- Root cause analysis of Quality related issues and implementation of C.A.P.A (corrective and preventative action) through proper documentation
- Evaluation and closure of deviation
- Evaluation and closure of change control with proper documentation
- Assuring cGMP compliance by solving product related issues
- Assuring proper coordination with other departments for smooth functioning of the system
- Oversight of weighing and movement of class II, III, and IV controlled drug materials
Quality Control Analytical Chemist
Epic Pharmaceuticals, LLC
Laurelton, NY
10.2008 - 10.2010
- Quality control testing of pharmacokinetic pharmaceutical products, mainly in solid oral dosage form, with some topical suspension testing
- Testing of stability products, including Assay, related compounds, and Dissolution for diverse conditions and time points
- Testing of Raw materials, including Residue on Ignition, Particle Size, Heavy Metals, Assay, and other techniques
- Extensive Use of Instrumentation such as High Pressure Liquid Chromatography, U.VAbsorption Spectroscopy, Infrared Spectroscopy, Karl Fisher Moisture Detector
- Compliance to Standard Operating Procedures and cGMP regulations
- Extensive use of Microsoft Office and Empower software
Education
Bachelor of Arts - Chemistry
New York University
NY05.2008
Skills
- Quality Control
- Data Analysis
- Complex Project Management
- Creative Problem Solving
- Interpersonal Skills
- Oral Communication
- Written Communication
Timeline
Supplier Quality Specialist
Lohmann Therapy Systems LTS Corp.
11.2018 - Current
Quality Assurance Specialist III
Alcami Corporation
04.2017 - 11.2018
Quality Assurance Associate
Epic Pharmaceuticals, LLC
10.2010 - 04.2017
Quality Control Analytical Chemist
Epic Pharmaceuticals, LLC
10.2008 - 10.2010
Bachelor of Arts - Chemistry
New York University
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