Equipment Supervisor

• Jan 2020 - Present

Equipment Specialist

• Aug 2017 - Jan 2020

QA Specialist

• Dec 2016 - Aug 2017

Microbiologist II

• Oct 2015 - Sep 2016

Quality Control Analyst

• Oct 2010 - Oct 2015

Citra Labs, LLC, a Biomet Biologics company, develops and markets blood rejuvenation solution and citrate-based anticoagulants. My role was to contribute to the implementation of a new Production Clean Room Suite (PCRS) for manufacturing operations. Primary roles include cGMP microbiological testing, coordinating metrology program, purchasing and release of materials and validation. I organized the metrology program and developed business relationships with associated vendors. I managed… Show more Citra Labs, LLC, a Biomet Biologics company, develops and markets blood rejuvenation solution and citrate-based anticoagulants. My role was to contribute to the implementation of a new Production Clean Room Suite (PCRS) for manufacturing operations. Primary roles include cGMP microbiological testing, coordinating metrology program, purchasing and release of materials and validation. I organized the metrology program and developed business relationships with associated vendors. I managed the calibration of production equipment, WFI Distribution, WFI Still, and USP water systems. I also performed in-process testing for TOC/Conductivity, bioburden, pH, endotoxin (kinetic and gel-clot), and environmental monitoring for viable, non-viable, and surface testing. I assembled batch records for QA approval, commercial batch release, and regulatory compliance. I created and revised Standard Operating Procedures (SOPs) for in-process methods and initiated and investigated deviations and OOS’ per SOP using various root cause analysis methods. I created P.O's for purchasing and release incoming shipments from suppliers and worked in collaboration with production team members to sample, ship, and record batch tests for sterility, particulate, and assay testing. Show less Citra Labs, LLC, a Biomet Biologics company, develops and markets blood rejuvenation solution and citrate-based anticoagulants. My role was to contribute to the implementation of a new Production Clean Room Suite (PCRS) for manufacturing operations. Primary roles include cGMP microbiological testing, coordinating metrology program, purchasing and release of materials and validation. I organized the metrology program and developed business relationships with associated vendors. I managed… Show more Citra Labs, LLC, a Biomet Biologics company, develops and markets blood rejuvenation solution and citrate-based anticoagulants. My role was to contribute to the implementation of a new Production Clean Room Suite (PCRS) for manufacturing operations. Primary roles include cGMP microbiological testing, coordinating metrology program, purchasing and release of materials and validation. I organized the metrology program and developed business relationships with associated vendors. I managed the calibration of production equipment, WFI Distribution, WFI Still, and USP water systems. I also performed in-process testing for TOC/Conductivity, bioburden, pH, endotoxin (kinetic and gel-clot), and environmental monitoring for viable, non-viable, and surface testing. I assembled batch records for QA approval, commercial batch release, and regulatory compliance. I created and revised Standard Operating Procedures (SOPs) for in-process methods and initiated and investigated deviations and OOS’ per SOP using various root cause analysis methods. I created P.O's for purchasing and release incoming shipments from suppliers and worked in collaboration with production team members to sample, ship, and record batch tests for sterility, particulate, and assay testing. Show less

QC Microbiologist (contract)

• Jan 2009 - May 2010

Lonza is a mid sized Biopharmaceutical company that provides contract manufacture of monoclonal antibodies (mAbs) and recombinant proteins from mammalian cell culture. Primary duties would include conducting Bioburden, Endotoxin (gel-clot), Environmental Monitoring testing in Class 100 (ISO 5), Class 10,000 (ISO 7) and Class 100,000 (ISO 8) clean room environments. Sampled from WFI, USP, and clean steam ports using proper aseptic technique. Paperwork for deviations and site excursions… Show more Lonza is a mid sized Biopharmaceutical company that provides contract manufacture of monoclonal antibodies (mAbs) and recombinant proteins from mammalian cell culture. Primary duties would include conducting Bioburden, Endotoxin (gel-clot), Environmental Monitoring testing in Class 100 (ISO 5), Class 10,000 (ISO 7) and Class 100,000 (ISO 8) clean room environments. Sampled from WFI, USP, and clean steam ports using proper aseptic technique. Paperwork for deviations and site excursions. Collaborated with functional group to organize performance quality sampling. Organized laboratory with proper items, monitored inventory, and placed orders for new supplies. Show less Lonza is a mid sized Biopharmaceutical company that provides contract manufacture of monoclonal antibodies (mAbs) and recombinant proteins from mammalian cell culture. Primary duties would include conducting Bioburden, Endotoxin (gel-clot), Environmental Monitoring testing in Class 100 (ISO 5), Class 10,000 (ISO 7) and Class 100,000 (ISO 8) clean room environments. Sampled from WFI, USP, and clean steam ports using proper aseptic technique. Paperwork for deviations and site excursions… Show more Lonza is a mid sized Biopharmaceutical company that provides contract manufacture of monoclonal antibodies (mAbs) and recombinant proteins from mammalian cell culture. Primary duties would include conducting Bioburden, Endotoxin (gel-clot), Environmental Monitoring testing in Class 100 (ISO 5), Class 10,000 (ISO 7) and Class 100,000 (ISO 8) clean room environments. Sampled from WFI, USP, and clean steam ports using proper aseptic technique. Paperwork for deviations and site excursions. Collaborated with functional group to organize performance quality sampling. Organized laboratory with proper items, monitored inventory, and placed orders for new supplies. Show less

Lab Student Research

• Jan 2007 - Dec 2008

Worked under direction of Department Profesors. Examined patient specimens using Gas Chromatography. Carefully collected blood samples from hamster patients and centrifuged the samples for analysis and extraction of plasma. i gained certification with The Institutional Animal Care and Use Committee (IACUC). Earned university newspaper appraisal for a descriptive and comprehensive presentation about the genetic pathways, physiological activities, and future clinical applications of Vitamin… Show more Worked under direction of Department Profesors. Examined patient specimens using Gas Chromatography. Carefully collected blood samples from hamster patients and centrifuged the samples for analysis and extraction of plasma. i gained certification with The Institutional Animal Care and Use Committee (IACUC). Earned university newspaper appraisal for a descriptive and comprehensive presentation about the genetic pathways, physiological activities, and future clinical applications of Vitamin D.Processed samples for measurement in University studies, Particle Sizer, HPLC, ELISA, and MS under the supervision of university professors. Show less Worked under direction of Department Profesors. Examined patient specimens using Gas Chromatography. Carefully collected blood samples from hamster patients and centrifuged the samples for analysis and extraction of plasma. i gained certification with The Institutional Animal Care and Use Committee (IACUC). Earned university newspaper appraisal for a descriptive and comprehensive presentation about the genetic pathways, physiological activities, and future clinical applications of Vitamin… Show more Worked under direction of Department Profesors. Examined patient specimens using Gas Chromatography. Carefully collected blood samples from hamster patients and centrifuged the samples for analysis and extraction of plasma. i gained certification with The Institutional Animal Care and Use Committee (IACUC). Earned university newspaper appraisal for a descriptive and comprehensive presentation about the genetic pathways, physiological activities, and future clinical applications of Vitamin D.Processed samples for measurement in University studies, Particle Sizer, HPLC, ELISA, and MS under the supervision of university professors. Show less