Cristina T. Coronado

Tox Lab QA/QC Officer at Phamatech, Inc
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Contact Information
us****@****om
(386) 825-5501
Location
California, United States, US

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Experience

    • United States
    • Biotechnology Research
    • 1 - 100 Employee
    • Tox Lab QA/QC Officer
      • Mar 2019 - Present

      15175 Innovation Dr Purchasing and receiving all incoming Materials for both the Tox lab and DOT lab and keep physical inventory, point of contact with vendors. Creating, tracking and file records of all purchases. Research the purchase of new reagents, parts, lab material and finding vendors as needed. Oversee that entries are done correctly in all log books and the maintenance/calibration of lab equipment. Preparation of Buffers, controls, and Internal Standards (I.S.) for Tox lab and DOT. Oversee… Show more Purchasing and receiving all incoming Materials for both the Tox lab and DOT lab and keep physical inventory, point of contact with vendors. Creating, tracking and file records of all purchases. Research the purchase of new reagents, parts, lab material and finding vendors as needed. Oversee that entries are done correctly in all log books and the maintenance/calibration of lab equipment. Preparation of Buffers, controls, and Internal Standards (I.S.) for Tox lab and DOT. Oversee validations for all new prepared reagents. Monitor the needs for drug controls, and broker the formulation of new controls with vendors. Oversee validation testing for new lots of purchased controls. Assigning lot numbers and expiration dates to all reagents prepared in-house and assigning expiration dates to purchased reagents, file CoA’s and MSDS. Assist with internal audits. Monitoring D.I. water usage, oversee the replacement of thanks, filters and lamps when needed and been point of contact with D.I. water vendor (EVOQUA). Assisting with the disposal of hazard chemical waste and Bio-hazardous waste produced by the lab, also assisting with the updates on the San Diego County website CERS of the amounts and types of hazard waste produced by the company. Create and maintain records of all vendors, vendor catalogs, reagents, parts and materials related to the lab. Resolve shipping, delivery and payment issues with vendors and assist with keeping the costs to a minimum and keep an updated inventory on Netsuite (accounting software. Filing and keeping records of DEA forms 222 used for the purchase and usage of schedule I and II drugs used by the tox lab. Assist other departments (i.e. manufacturing) when needed with purchases or any there activity.

    • Production Lab Leader
      • Mar 2007 - Oct 2019

      San Diego Ca, 92121 Train, Supervise and interview personnel for the Chem Lab Served as point of contact for all the Chem Lab activities and support for the Chem Lab manager. Schedule personnel’s and Lab’s activities In charge of all in–house controls used for production and Quality Control of drug and hormonal devises. This included making them with synthetic drugs or high positive Urine, testing, inventory, ELISA’s for the hormonal controls (HCG, FSH, LH, HbsAg), distributing the controls to rest of… Show more Train, Supervise and interview personnel for the Chem Lab Served as point of contact for all the Chem Lab activities and support for the Chem Lab manager. Schedule personnel’s and Lab’s activities In charge of all in–house controls used for production and Quality Control of drug and hormonal devises. This included making them with synthetic drugs or high positive Urine, testing, inventory, ELISA’s for the hormonal controls (HCG, FSH, LH, HbsAg), distributing the controls to rest of the company and keeping track of them.(March 07-Sep 08) Prepared artificial urine, buffers and antibody. Production of conjugate solution for OPI, BAR, OXY, METH, AMP, COC, HCG, LH, FSH and HBsAg Ion exchange antibody purification for Goat anti Mouse, Goat anti Rabbit, AntiHCG Colloidal gold production Electrophoresis with SDS-Page Gel

    • United States
    • 1 - 100 Employee
    • Production Chemist II
      • Oct 2012 - Feb 2015

      Greater San Diego Area Antibody purifications by the following methods: Ion exchange, size exclusion, and affinity. Experience performing bench top antibody purifications and with ÄKTA Bioprocessor with Unicorn software. Concentration and Diafiltration of antibodies with Sartorius membranes and Vivaflow systems. Analysis of antibodies via SDS-Page Gel and HPLC to confirm final purity. Prepared Strep A, B, C, G cultures and suspension, as well as Strep A, C and G microtiter plates for Strep A Screening of… Show more Antibody purifications by the following methods: Ion exchange, size exclusion, and affinity. Experience performing bench top antibody purifications and with ÄKTA Bioprocessor with Unicorn software. Concentration and Diafiltration of antibodies with Sartorius membranes and Vivaflow systems. Analysis of antibodies via SDS-Page Gel and HPLC to confirm final purity. Prepared Strep A, B, C, G cultures and suspension, as well as Strep A, C and G microtiter plates for Strep A Screening of rabbit serum. Documented all manufacturing processes in real time using Manufacturing Record Procedures (MRP) and Quality Test Procedures (QTP) per GMP, ISO and FDA guidelines. Perform trouble-shooting of various manufacturing processes when needed and properly document them in the MRP or in a Non Conformance Report (NC) if necessary. Identification of Deviations and Non Conformances in manufacturing processes. Revised and updated MRP for various manufacturing processes and revamped all MRP’s used in Strep manufacturing. Antibody filter conjugates and latex conjugates. Trained chemists in Strep processes. Show less

    • Peru
    • Biotechnology Research
    • Production Chemist I
      • Sep 2008 - Jan 2009

      San Diego Ca, 92121 Responsible for the formulation and testing of molecular biology grade reagents. Assist with planning and scheduling reagent manufacturing activities. Provided support to all operations pertinent to reagent manufacturing.

    • United States
    • Pharmaceutical Manufacturing
    • Intern Technitian
      • Jul 2006 - Jan 2007

      San Diego, Ca Histoculture and Xenograft Cancer cell Culture (cell lines propagation). LN2 tank maintenance. Training in mice techniques (IP, IM, SC, OP, ID, IV, and eye bleeds).

Education

  • Instituto Tecnológico de Tijuana
    BS, Biochemical Eng.
    2001 - 2006

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