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Quality Control Assurance

Location:
Rochester, New York, United States
Posted:
January 24, 2018

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Resume:

Jill Gresens

ac36d2@r.postjobfree.com

*** ******* **.

Rochester, NY 14617

585-***-****

Education

University of Wisconsin - Madison

**** – Earned B.S. in Medical Microbiology and Immunology

Relevant Experience

Ward’s Science: Product Specialist

October 2016 – Present

Responsible for 3 diverse product categories totaling approx. $7M in annual revenue.

Research competitor product offerings and pricing, and understand market trends

Owner for product SAP Master Data, web and catalog presentation and pricing.

Interaction with regulatory agencies to obtain relevant permits to import, raise and transport various specimens to customers. (USDA, NY State Dept. of Ag and Markets, CITES, US Fish and Wildlife, etc.)

Ward’s Science: Biology Category & Specimens Supervisor

October, 2012 – October 2016

Owner of manufacturing process from start to finish (receiving, production, quality control and shipping) for six production laboratories.

Daily supervision of a staff of 13 technical personnel (performance reviews, salary recommendations, goal setting and disciplinary action.)

Implemented performance metrics for the department.

Initiated and participated in Ward’s first Six Sigma Kaizen Event process improvement project, resulting in a 20% decrease in non-value add process time for production facility.

Val Tech Holdings LLC: Quality Control Microbiologist

May, 2011 – October, 2012

Introduced and validated bioburden test for new beverage product line, and revised bioburden testing procedures.

Fine-tuned environmental monitoring protocol and qualified new clean-room suite per standard: ISO 14644

Implemented quality metrics and created report for senior leadership.

CAPA Team member.

Compiled data results and all relevant attachments for batch records.

Reviewed and final Quality-sign-off off batch records for product final release.

Thermo Fisher Scientific (Nalge/Nunc): Quality Assurance Lab Technician

December, 2010 – May, 2011 (Temporary Position)

Performed various USP and laboratory tests for release/stability/sterility of plastic disposable lab ware (bottle-top filters, petri dishes, microtiter plates, etc.)

University of Rochester: Laboratory Technician – Toxicology

November, 2009 – December, 2010 (Temporary position)

Maintained colonies of mice per IUAUC regulations.

Dosed subjects via: gavage, intra-peritoneal injections, intra-nasal inoculation (aspiration).

Cook Pharmica, LLC:

Jul, 2008 – Jul, 2009 Quality Control Supervisor - Microbiology

Coordinated daily testing activities of 4 Microbiologists and 4 Microbiology Technicians.

Maintained testing schedule ensuring all required testing was performed in a satisfactory manner and in accordance with Pharmaceutical cGMPs per FDA’s Guidance for Sterile Drug Products.

Responsible for final review of routine testing data, validation projects, CAPAs as well as non-conformance investigations.

Dec. 2006 – Jul, 2008 Quality Control Microbiologist

Performed microbial environmental testing for facility clean rooms and associated water and compressed gas facilities.

Performed Microbiology Investigation Reports in response to any non-conformances.

Worked closely with engineering team to perform validation of autoclaves, and bio-reactors.

Performed sample testing (air, water, compressed gasses, surfaces) of new clean room suite during Environmental Monitoring Performance Qualification, as well as ongoing testing after qualification.



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