Stephanie Montville Cerbone

Stephanie montville cerbone

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location of Stephanie Montville CerboneWindsor, Connecticut, United States
Followers of Stephanie Montville Cerbone775 followers
  • Timeline

  • About me

    ♛ Quality and Compliance GURU ♛ Focused on Global Harmonization and Improvement

  • Education

    • University of new haven

      2002 - 2006
      Bachelor of science (bs) forensic science
  • Experience

    • Sanofi genzyme

      Nov 2007 - May 2016
      • Principal Quality Control Analyst

        Mar 2015 - May 2016
      • Senior Quality Control Analyst

        Apr 2012 - Mar 2015
      • Quality Control Analyst II

        Mar 2009 - Apr 2012
      • Quality Control Analyst I

        Nov 2007 - Mar 2009
    • Avista pharma solutions, inc.

      May 2016 - Oct 2017
      Qa manager

      Avista Pharma Solutions is a contract testing, development and manufacturing organization encompassing over 200,000 square feet of laboratory and manufacturing space across three locations (Agawam, MA – Durham, NC – Longmont, CO), providing pharmaceutical, animal health and medical device clients with a broad suite of scientifically-differentiated services ranging from early drug development and drug product manufacturing to stand-alone analytical and microbiology testing support.OUR CAPABILITIES INCLUDE:Drug Substance Development & ManufacturingDrug Product Development & ManufacturingProcess ChemistryAnalytical Development, Validation & TestingMicrobiology & Environmental MonitoringAnimal Health Anti-Parasitic Screening & Discovery Show less

    • Idex health & science, llc

      Oct 2017 - Feb 2018
      Manager, quality and regulatory
    • Sca pharma

      Feb 2018 - Oct 2024

      SCA Pharmaceuticals is a nationally recognized FDA 503B outsourcing facility specializing in providing the highest quality sterile admixture services and pre-filled oral syringes to hospital pharmacies. Choosing to outsource products with SCA alleviates common problems health care facilities face such as wasted product, drug shortages, time-consuming processes, compliance issues, staffing costs, and patient safety concerns. Our state of the art facility exceeds USP <797> standards, meets cGMP requirements, and will be expanding as our team continues to grow. Our very talented, experienced, and dedicated team of professionals are committed to providing the safest products for patients. It is our policy to create a partnership with our customers based on values, quality, innovations, and patient safety. Show less

      • Director, Global Quality Systems & Technical Support

        Dec 2021 - Oct 2024
      • Senior Manager, Global Quality Systems

        Jul 2018 - Dec 2021
      • Supplier Quality Manager

        Feb 2018 - Jul 2018
    • Cerbone pharma consulting

      Sept 2024 - now
      Founder & consultant

      https://www.cerbonepharmaconsulting.com/

    • Berkshire sterile manufacturing

      Nov 2024 - now
      Senior director, quality
  • Licenses & Certifications

    • Lean six sigma green belt

      Lean sigma corporation
      Dec 2014
  • Honors & Awards

    • Awarded to Stephanie Montville Cerbone
      SCA Pharma Above and Beyond Award SCA Pharma Apr 2022
    • Awarded to Stephanie Montville Cerbone
      Genzyme Breakthrough Award CQO QCTS Feb 2016
    • Awarded to Stephanie Montville Cerbone
      CQO Breakthrough Award CQO QCTS Nov 2015
    • Awarded to Stephanie Montville Cerbone
      Genzyme Breakthrough Award CQO QCTS Sep 2015
    • Awarded to Stephanie Montville Cerbone
      Genzyme Breakthrough Award CQO QCTS Jun 2015
    • Awarded to Stephanie Montville Cerbone
      Genzyme Breakthrough Award CQO QCTS Sep 2014 This award was given in recognition of my leadership and management skills for a massive laboratory move from one building to another. In total, more than 100 pieces of equipment needed to move and be re-qualified in their new location.
    • Awarded to Stephanie Montville Cerbone
      Genzyme Breakthrough Award CQO QCTS Apr 2014
    • Awarded to Stephanie Montville Cerbone
      Genzyme Breakthrough Award CQO QCTS Oct 2013
    • Awarded to Stephanie Montville Cerbone
      Genzyme Breakthrough Award CQO QCTS Sep 2013
    • Awarded to Stephanie Montville Cerbone
      Genzyme Breakthrough Award CQO QCTS Aug 2013
    • Awarded to Stephanie Montville Cerbone
      Genzyme Breakthrough Award CQO QCTS Feb 2013
    • Awarded to Stephanie Montville Cerbone
      Genzyme SPOT Award Genzyme Biosurgery Oct 2011