Kristen Friesen

QC Supervisor at Emergent BioSolutions
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Contact Information
us****@****om
(386) 825-5501
Location
CA

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5.0

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Ivan A. Salazar

Kristen has a quick grasp of technical issues and the maturity to work well within a diverse team under stressful circumstances. She takes initiative displaying leadership and keeping the overall departmental strategy in mind when executing her day to day supervisory duties. She is fair and open to new ideas as long as they further our common goals and objectives. It was a delight to work with her at Cangene. I highly recommend her in her future endeavors.

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Experience

    • United States
    • Biotechnology Research
    • 700 & Above Employee
    • QC Supervisor
      • Apr 2020 - Present

    • Laboratory Technician
      • Nov 2015 - Apr 2020

    • Trainer
      • Mar 2013 - May 2014

      Conduct orientations and on-the-job training for new employees and regular staff.Develop & organize training materials for Production & Health and Safety.Maintain training records.Applies all regulations, corporate policies and workplace health and safety within the plant during supervision.Substitute for all on-floor supervisors and Production coordinator when required.

    • Product Quality Supervisor
      • Apr 2012 - Mar 2013

      Complete daily review, verification and submission of all incoming inspection reports used to process chargebacks to agencies. Notify the Director of Quality Assurance and applicable Field Operation Manager of large or recurring problems with incoming quality. Institute corrective actions and placed “holds” on non-conforming product as required. Monitor on floor holds pending disposition. Complete all inventory and aged shelf life inspections. Record & report results of the weekly on-floor hygiene audits.Ensure the quality and safety of product through the supervision of the HACCP program and on-floor union staff Quality Assurance Inspectors.Update all quality databases and formulate monthly reports for the Director of Quality Assurance. Show less

  • Cangene Corp.
    • 155 Innovation Drive
    • Quality Control Raw Material Technician
      • Aug 2009 - Jan 2012

      I performed analysis on raw materials and entered results according to GMP guidelines which ensured materials met required specifications. I contributed product development which included testing and analysis for various project related materials. Materials were then sent to Research & development for further analysis. I purchase lab equipment and chemicals for raw material testing, by following inventory guidelines which ensured production requirements were met. I followed current SOP’s and STM’s accurately to complete testing and release of raw materials while adhering to strict deadlines. I wrote qualification reports and analytical specifications for incoming materials. These reports were used to establish secondary supplier contracts to ensure adequate supply of materials. I initiated change controls to update SOP’s & STM’s to implement revisions as required by regulated bodies or as by supplier request which ensured up to date testing requirements. I initiated non-conformance and corrective action reports when required, implemented changes as necessary to reduce future errors. Show less

    • Fermentation Supervisor
      • Oct 2007 - Aug 2009

      I supervised, coordinated and organized duties to meet production timelines which resulted in improved efficiency of processes. I developed performance qualification records for equipment to facilitate consistent manufacturing processes.I helped design a new training program for employees, which streamlined training and helped to further team effectiveness.

    • Fermentation Group Leader
      • Feb 2007 - Oct 2007

      I acted as key contact when the supervisor was unavailable by assisting with the organization of shifts to ensure all manufacturing processes were on schedule.I followed proper gowning and sanitization procedures for aseptic culture propagation for biopharmaceutical raw materials.I assisted with training and competency assessment for all new technicians to ensure smooth production operation.

    • Fermentation Technican
      • Sep 2003 - Feb 2007

      Aseptic culture propagation for biopharmaceutical raw materials I have practical experience in cGMP facility sanitation requirements including CIP/SIP’s.Product recovery using extensive filtration, centrifugation and numerous other bio-separation techniques.I assisted with training and competency assessment for all new technicians.

    • QC Technician
      • 2003 - 2003

Education

  • Red River College
    Chemical and Biosciences Technology Diploma
    2001 - 2003

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