Quality Assurance

Objective

To obtain a poisition withing a company that will enable me to continue growing my career using my strong laboratory skills, educational background and ability to work well with people.

Experience

Pharmedium – Quality Scientist February 2017 – Present

Performing Sterility and Endotoxin testing using aseptic techniques on various types of pharmacuetical products.

Testing the ID and Potency of pharmacuetical products using Atomic Abosrbtion and UV-VIS spectroscopy.

Conducting NOE and Laboratory investigations for out of specification resutls.

Trending data for the out of specification results and deviations to the SOPS.

Performing Daily/Weekly Calibrations of different insturments ultalized in the labaratory for testing products.

West-Ward Pharmaceuticals - Quality Lab Associate I November 2013 – December 2016

Perform routine Envrionmental Monitoring and Anylatical sampling using aseptic techniques.

Envrionmental Testing – Air and Surface

Analyatical Testing – Bioburden, LAL Water, Endotoxin.

Review and update Standard Operating Procedurecs (SOP’s).

Initiated protocol to meet the standards for the deviations of the SOPs.

Participation in execution of new filling rooms qualifications and validations.

Qualified three new filling rooms in the facility with the accordance of the FDA and CGMP requirements.

Conducted Smoke Study and participated in Media Fill trials.

Conduct laboratory investigation reports regarding deviations from the SOPS / micorbial growth incidents upon discovery.

Monitors, performs and documents sampling / testing and inspection of raw materials / components / in-process samples and documents the results in compliance with cGMP and company procedures.

Aseptic Gowning Trainer

Rosenberg’s Diary – Quality Technician December 2012 – November 2013

Followed SOPs and GLPS and monitored equipment performance using aseptic technique and oversee addition of active ingreditens in compounding.

Testing Raw products for Quality Assurance.

Documentation of all calibrations and usage of the instruments in the lab.

Plating the products using aseptic techniques for various test such as E-Coli, Gram Stain, Yeast and Mold.

Reading and recording the resuts of the test in the company database.

Preparing documents for audits such as SQF.

Flavor testing each product before shipment.

Scribe for America - Scribe March 2012 – July 2012

Working at Nazareth Emergency Department with doctors to obtain patients HPI (history of illness) and Chief complaint.

Documentation of patients history and their reason for coming to the Emergency Department.

Updating/Recording the resuts of the patients test from patients physical exams.

Calling the patients primary care doctors for the patients records

Education

Temple University – Bachelor of Science Biology December 2012

Graudated with Honors Roll.

Participated in research project for Anti-Cancer therapy by treating the cancer cells with chemotherapy agents and running PCR to view the regulation of different genes.

Relevant Coursework:

Cell Proliferation Organic Chemistry Stem Cell Research

Cell Structure and Function Microbiology Genetics.

Skills

Microsoft Word and Excel

4 years of working in cGMP setting

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