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Quality Control Manager

Location:
Aventura, FL
Posted:
September 25, 2015

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Resume:

Reynier Rodríguez Huerta **** SW *nd Street Miami, Florida, 33144, Cell Phone: 305-***-****, E-mail: acruis@r.postjobfree.com

PROFILE

Bachelor Degree in Microbiology, University of Havana. Proficient in Quality Control-Microbiology and experienced in developing analytical methods and validation tests.

PROFESSIONAL EXPERIENCE

Sentry Manufacturing, Inc. Miami Lakes, Fl. (2015)

QA in Sentry Manufacturing.

-Quality Assurance.

-Perform Quality Test in capsules and Tablet such: hardness, Friability, Disintegration, Thickness and Weight Variation.

-Perform Visual Inspection of each product.

-Complete and review Batch Record accountability.

-Data Entry (Prepared Batch manufacturing Records)

-Documentation of log books, Calibration records, Temperature and Humidity records.

Center of Immunoassay. Specialist in biological assays. (2006-2009)

-Ultramicro diagnostics system (UMELISA) SUMA Technology.

-PSA UMELISA applied in the research of prostate cancer in the National Health Network of Cuba.

-UMELISA IgE detection, applied in the research related to allergic children.

-UMELISA HCG, applied in the diagnosis of pregnancy, combined with AFP UMELISA Down’s syndrome diagnosis and as a tumour marker.

-AFP UMELISA applied in the diagnosis of neural tube birth defects, and as a tumour marker.

Center of Molecular Immunology. Specialist B in Quality Control. (2009-2014)

Microbiology Group of Department of Quality Control at Center of Molecular Immunology.

-Filtration method for determining bioburden in recombinant protein, antibodies, purified water and water for injection samples.

-Endotoxins determination (LAL) in recombinant protein, antibodies, purified water and water for injection samples by kinetic turbidimetric and kinetic chromogenic methods.

-Analyse purified water and water for injection samples by TOC.

-Performance qualification of pharmaceutical water systems, purified water, water for injection, clean steam generator and compressed air system on Mab production plant at Center of Molecular Immunology.

Biochemistry Group of Department of Quality Control at Center of Molecular Immunology.

-Determination of identity and purity of recombinant protein and antibody samples by HPLC.

-Developing of PCR method for the detection of Mycoplasma spp in antibodies and recombinant proteins harvests. Detection of contaminant DNA by hybridization, in antibodies and recombinant proteins harvests.

-Determination of identity and purity in recombinant protein by SDS-PAGE.

-Protein concentration by UV.

-Determination of biological activity of antibodies by flow cytometry.

EDUCATION

Bachelor of Science, major Microbiology (2006). Faculty of Biology of the University of Havana, Cuba.

SKILLS

-Ability to work in a multi-cultural environment and participate in a team atmosphere.

-Ability to propose, manage and implement research projects.

-Effective at applying critical thinking and time management in any work environment.

-Ability to produce high quality work in a timely fashion.

-High sense of responsibility, and very organized person.

-Expertise in Microsoft word, Excel, PowerPoint.

-Fluent in English and Spanish.

-Ability to read and interpret at documents.

-Mathematical skills.



Contact this candidate