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Safety Clinical Research

Location:
New York, NY
Salary:
80,000
Posted:
May 03, 2016

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Resume:

DIANA K. ABERIN

** ******** ***** ***** *****, NJ 08882 732-***-**** acumcp@r.postjobfree.com

Highly Motivated and

Experienced in Quality, Regulatory, and Clinical Professional Fields

QUALIFICATIONS

• Familiar with laboratory procedures and cGMP regulations

• 4 years experience in R&D/compliance roles (medical diagnostics and cosmetics)

• Ability to work independently; also works well and communicates with others especially in fast paced team environment

• Excellent attention to detail, adherence to timelines, and able to handle multiple projects effectively and efficiently

• Technical proficiency includes MS Word, Excel, PowerPoint, Windows 2000, XP, Vista, SAP, SQL

EDUCATION

UNIVERSITY OF THE SCIENCES, Philadelphia, Pennsylvania August 2007-May 2011

Bachelor of Science in Pharmacology and Toxicology

WORK HISTORY

Revlon Research Center, Edison, New Jersey

Associate Safety Specialist – R&D - Global Regulatory & Safety August 2014 – present

• Performed preservative efficacy and microbial content testing on cosmetic products

• Conducted Epiocular in-vitro assays to screen for ocular irritancy

• Reviewed raw material paperwork and product formulas for safety and global regulatory compliance and determined testing requirements

• Served as a liaison/sponsor monitor between Revlon and external CROs to outsource clinical testing within critical timelines in order to support business and product compliance needs

• Attended category meetings with cross functional groups and senior members to provide feedback and status updates about ongoing and proposed clinical studies

• Managed annual clinical safety testing budget and handled contract negotiations with CROs

• Reviewed and approved protocols for accuracy for clinical safety studies, monitored adverse events, and analyzed results in final reports

• Organized records and essential documents for clinical testing reports and tracked all clinical study projects through internal database and office files

Zeus Scientific, Inc., Branchburg, New Jersey

QA/QC Associate – Biosafety Level 2 Facility August 2012 – July 2014

• Performed ELISA, Western Blot, and Immunofluorescence assays on plasma/serum samples to screen for various disease states

• Conducted quality control testing on finished goods to ensure compliance with internal company standards and SOPs

• Processed plasma to be used as controls in ELISA products

• Reviewed incoming raw material acceptance paperwork, production batch records, and signed for final approval

• Conducted weekly audits of production labs and manufacturing areas to ensure cGMP and FDA compliance

R&D Lab Technician April 2012 – August 2012

• Worked in a laboratory clean room to produce beadmill tubes in mass quantities to be used in experiments for the detection of microbes

• Assisted other R&D techs with various experiments (PCR, blood and urine sample preparations)

• Loaded out and labeled components for pilot lots

• Cleaned and maintained laboratory equipment (laboratory hoods, centrifuge machines and rotors, bleach preparation)

ORGANIZATIONS

Personal Care Products Council October 2015 – present

Society of Clinical Research Associates (SoCRA) April 2016 – present



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