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Quality Assurance Technician

Location:
Rochester, NY
Posted:
September 19, 2013

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Resume:

Angela Stetson

*** ***** ****

Rochester, NY ****2

585-***-****

ab76ml@r.postjobfree.com

I want to obtain a position that values attention to details, thoroughness, dedication and the willingness to

g o the extra mile.

Education

St. John Fishers College, Rochester NY B.S. Biology-major Chemistry-minor, '98

Greece Arcadia High School, Rochester NY Regents Diploma

Skills

Understanding and compliance of GLP and GMP procedures.

Experience in establishing protocols and SOP's in conjunction with FDA, ISO and USP guidelines and working

with quality assurance including internal and external audits.

Detail orientated and diligent regarding compliance.

Excellent analytical abilities, experienced with study design and troubleshooting.

Able to work independently on multiple projects within specific deadlines.

Knowledge of standard laboratory equipment.

Experience in handling biohazardous agents Biosafety Levels 1, 2 and 3.

Animal husbandry, IV injections, necropsies

Experience in Microsoft Office

Relevant Experience

Lab Technician for Kelly Services at Johnson & Johnson OCD (10/2012 – present)

Conducted primary and release testing on Vitros System Immunodiagnostic medical devices. Used quality record

practices in timely and accurate completion of the Device History Record (DHR). Required to meet and exceed key

performance measure that include; quality of work, DHR accuracy, productivity and continuous improvement. Used

Laboratory Information Management System (LIMS), ERP, SAP, (Crossroads) and Qerts (Trackwise).

Lab Technician at Lake Immunogenics (04/2009 - 12/2010)

Oversaw BSL2 Laboratory compliance with select agent regulations including preparation of biosafety and emergency

manuals. Implemented and maintained OSHA, MSDS and safety programs. Prepared regulatory documents including

but not limited to outlines of production, protocols, SOP's, audit responses and AAALAC and AALAS processes.

Communicated with USDA, CDC on both existing and new products in development. Conducted literature searches and

maintained global relationships with professionals with similar research. Created and maintained computer logs and

calculation sheets. Utilized in vivo and in vitro models in experiments. Conducted product testing (ELISA, RIA, MNA,

etc.) and entered/tracked data analyzing results to schedule immunizations. Prepared immunizations (microbial and

toxins) according to schedule coordinated with veterinary staff to continue manufacturing of all licensed products.

Prepared, ordered, inventoried and stocked all of the laboratories needs including but not limited to reagents, equipment,

calibrations, toxins, live animals and removal of regulated medical waste and disinfectant solutions company wide. Kept

bacterial seed culture isolates (R.equi, S aureus), venoms and toxins for immunization/antigen preparations. Prepared

tissue for study using histochemical techniques.

Toxicology Technician II Ethox International (08/2006 - 10/2008)

Primarily responsible for in vivo and in vitro testing of medical products and devices: including but not limited to;

pyrogenicity, irritation and intracutaneous reactivity, sensitization, acute systemic, abnormal toxicity, safety tests,

implantations and hemocompatability. AAALAC accredited and AALAS member. Audited by USDA, FDA and

NYSDOH. Documentation, GLP notebook practices, deviations (CAPA), equipment calibrations.



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