Management Quality Assurance

Albertine (Eleen) Benjamin

**** ********* ****, *********, ** 91302 818-***-**** *************@*******.***

Pharmaceutical Research Professional

Biotechnology Research Drug Design & Informatics Laboratory Diagnostics

Accomplished, analytical and goal-oriented professional with a comprehensive biotechnology and pharmaceutical research background. Master of Science degree in Regulatory Affairs, with proficiency in conducting Clinical Safety Reviews (CSR); drafting abstracts based on clinical studies; and translating complex manuscripts. Knowledgeable in Integrated Summary of Safety (ISS) and Life Cycle Management Summaries. Extensive technical and academic laboratory diagnostics experience, with expertise in Good Management Practice (GMP) and Good Clinical Practice (GCP) standards.

Clinical Safety Review

Life Cycle Management

Drug Design & Informatics

Good Clinical Practice (GCP)

Regulatory Compliance

Regulatory Labeling

Laboratory Diagnostics

Procedure Management

Quality Assurance

Strategic Planning

Database Management

Microsoft Office

Education

Master of Science, Regulatory Affairs, George Washington University

Coursework included: Analysis Regulatory Affairs, Regulatory Strategy in the Development of Drugs and Biologics, Regulatory Strategy in the Development of Devices and Diagnostics, Regulatory Device Diagnostics, Regulatory Affairs Compliance, Regulatory Drug Biologics, Clinical Research for Regulatory Affairs, Leadership in Regulatory Affairs, Introduction to Global Regulatory Affairs, Health and Clinical Research and Issues and Trends in the Healthcare System

Master of Science, Biotechnology/Bioinformatics, California State University at Channel Islands

Bachelor of Science, Biology, California State University at Stanislaus

Professional Experience

AMGEN, Thousand Oaks, CA

Senior Stability Associate (2011-2012)

Verified studies and stability data tables while maintaining alignment with GMP guidelines.

Maintained data in the Sample Manager Laboratory Information Management System (SM LIMS).

Assisted in Authoring regulatory filing sections of reports and data findings, as well as stability technical reports.

Assisted in protocol design and stability studies’ execution to support product shelf life.

Research Associate - Pharmacokinetics & Drug Metabolism (2008-2009)

Developed and validated analytical methods and assay samples.

Ensured that projects were in compliance with GCP guidelines.

Utilized enzyme-linked immunosorbent assay (ELISA) techniques for stability study on plates.

Conducted research for a variety of projects pertaining to antibody detection and antibody assay studies.

Evaluated data using various systems such as Softmax Pro and Excel.

ABAXIS, Union City, CA 2001 – 2004

Quality Assurance and Quality Control Client Support

Managed project design elements involving client communication and the preparation of deliverables.

Coordinated weekly team meetings with management to provide progress updates.

Designed validation and analysis studies for equipment and reagents in a clinical laboratory setting.

Investigated and resolved client concerns, including performing in-house testing on recreated issues.

Performed stability and accuracy analyses on newly developed assays.

Calibrated assays in adherence with veterinary standards.

Contributed to the development and review of Standard Operating Procedures (SOP).

DADE BEHRING, San Jose, CA 1999 – 2001

Clinical Application Specialist

Ensured that all company products met worldwide regulatory requirements.

Developed product submissions for the Food and Drug Administration (FDA) and other regulatory agencies.

Coordinated document packages for regulatory submissions ensuring compliance with FDA.

Major accomplishment: shortened product launch period by improving efficiency of product support analysis functions;

Monitored clinical trials [on Drugs of abuse and therapeutic drugs assays]

Certified operators and instruments on chemistry systems;

Provided systems analysis to senior management to ensure support function meets company’s strategic goals;

Documentation creation and management for calibration and control documents, reports and journals for validation studies;

Blood analyzer equipment validation and monitoring studies, including linearity, long term reagent stability, comparison, and accuracy testing (Olympus, Beckman, Hitachi, Syva, Viva, and Mira Blood Analyzers)

Support for Clinical Application including instrument maintenance and calibration, laboratory supplies, maintaining laboratory log books using GLP knowledge

Conducted equipment validation according to Companies regulations (Olympus, Hitachi, Syva, and Mira blood analyzers)

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