Macario Hurtado, CQA
Quality Manager at Spherotech, Inc- Claim this Profile
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Topline Score
Bio
Experience
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Spherotech, Inc
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Biotechnology Research
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1 - 100 Employee
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Quality Manager
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Sep 1999 - Present
Biotechnology/Pharmaceuticals ISO9001:2008 Lead Auditor. Management Representative at Spherotech. Responsible of the following Processes: Document Control, Internal Audits, CAPA and Control of Records.. As Quality Representative responsible for the implementation and maintenance of the Quality Management System (ISO 9001:2008 with Design). Lead Auditor on Internal Quality Audits. As member of the Product Design Team participate in updating Product Design Projects. Participate… Show more Biotechnology/Pharmaceuticals ISO9001:2008 Lead Auditor. Management Representative at Spherotech. Responsible of the following Processes: Document Control, Internal Audits, CAPA and Control of Records.. As Quality Representative responsible for the implementation and maintenance of the Quality Management System (ISO 9001:2008 with Design). Lead Auditor on Internal Quality Audits. As member of the Product Design Team participate in updating Product Design Projects. Participate in the development of several catalog items: ACBP's, CPAK's, CMIgP's, ECFP's, RCP's, SVPAK's, URCP's, etc. Responsible for the Calibration Program. Participate in the Training program as required by the Organization. Participate in the development/review of quality control and standard operating procedures as needed.
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Manufacturing Associate
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Jun 1992 - Sep 1999
Biotechnology/Pharmaceuticals Develop/Design Manufacturing Processes: Functional, Magnetic, Fluorescent, Antibody and Protein Coated Microparticles (CMIgP's, EasyComp, SVPAK's, etc) Manufacture several types of coated (Streptavidin, Biotin, Glutathione, Antibody, etc) and un-coated microparticle formulations (Plain, Magnetic, Fluorescent, Functional, etc). Prepare Batch Record Sheets used in the manufacturing process of different components and finished goods. Prepare Material… Show more Biotechnology/Pharmaceuticals Develop/Design Manufacturing Processes: Functional, Magnetic, Fluorescent, Antibody and Protein Coated Microparticles (CMIgP's, EasyComp, SVPAK's, etc) Manufacture several types of coated (Streptavidin, Biotin, Glutathione, Antibody, etc) and un-coated microparticle formulations (Plain, Magnetic, Fluorescent, Functional, etc). Prepare Batch Record Sheets used in the manufacturing process of different components and finished goods. Prepare Material Specification/Analysis Sheets used in the evaluation of raw materials, in-process and finished good products. Maintain Inventories of Finished Products to ensure on time shipments. Prepare the production schedule to ensure products availability based on their forecast.
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Baxter International, Inc
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Research Associate
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Aug 1983 - Jun 1992
Biotechnology/Pharmaceuticals Develop/Design Microbead Assays (PCFIA Mouse Isotyping Kit, Streptavidin Particles, Antibody Coated, Etc,) Harvest Hybridoma Cells. Screen culture supernantants to isolate desired hybridoma cell lines. Participate/Develop DNA Assay (SLE PCFIA Assay)Prepare Solutions, Buffers and Cell Culture Mediums as needed. Autoclave materials, glassware and equipment as required. Participate in the development of an SLE PCFIA Assay. Develop several assays for… Show more Biotechnology/Pharmaceuticals Develop/Design Microbead Assays (PCFIA Mouse Isotyping Kit, Streptavidin Particles, Antibody Coated, Etc,) Harvest Hybridoma Cells. Screen culture supernantants to isolate desired hybridoma cell lines. Participate/Develop DNA Assay (SLE PCFIA Assay)Prepare Solutions, Buffers and Cell Culture Mediums as needed. Autoclave materials, glassware and equipment as required. Participate in the development of an SLE PCFIA Assay. Develop several assays for the evaluation of coated microparticles (Reactivity, Sensitivity, Cross-reactivity, etc,) Participate in the development of a Mouse Isotyping Kit for PCFIA Applications Show less Biotechnology/Pharmaceuticals Develop/Design Microbead Assays (PCFIA Mouse Isotyping Kit, Streptavidin Particles, Antibody Coated, Etc,) Harvest Hybridoma Cells. Screen culture supernantants to isolate desired hybridoma cell lines. Participate/Develop DNA Assay (SLE PCFIA Assay)Prepare Solutions, Buffers and Cell Culture Mediums as needed. Autoclave materials, glassware and equipment as required. Participate in the development of an SLE PCFIA Assay. Develop several assays for… Show more Biotechnology/Pharmaceuticals Develop/Design Microbead Assays (PCFIA Mouse Isotyping Kit, Streptavidin Particles, Antibody Coated, Etc,) Harvest Hybridoma Cells. Screen culture supernantants to isolate desired hybridoma cell lines. Participate/Develop DNA Assay (SLE PCFIA Assay)Prepare Solutions, Buffers and Cell Culture Mediums as needed. Autoclave materials, glassware and equipment as required. Participate in the development of an SLE PCFIA Assay. Develop several assays for the evaluation of coated microparticles (Reactivity, Sensitivity, Cross-reactivity, etc,) Participate in the development of a Mouse Isotyping Kit for PCFIA Applications Show less
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CONALEP
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Higher Education
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700 & Above Employee
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Instructor
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Aug 1981 - Mar 1983
National College of Profesional Technical Education | Mexico/D.F. Teach the following materias: Laboratory Techniques Fish & Feed Nutrition General Chemistry National College of Profesional Technical Education | Mexico/D.F. Teach the following materias: Laboratory Techniques Fish & Feed Nutrition General Chemistry
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Fisheries Department
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India
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Government Administration
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Laboratory Technician
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Sep 1979 - Jul 1981
Mexico/D.F Prepare and Evaluate Fish Diets Clean laboratory glassware Prepare solutions and culture mediums Mexico/D.F Prepare and Evaluate Fish Diets Clean laboratory glassware Prepare solutions and culture mediums
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Education
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Universidad Autónoma Metropolitana
Bachelors, Chemical-Pharmaceutical Biologist