Kathleen Adams

Experience

• 

  INova Pharmaceuticals

  Feb 2004 - Aug 2012

  Validating methods for a wide range of new and reformulated products for a pharmaceutical laboratory using HPLC (Agilent with EMPOWER2), UPLC, GC, UV-Vis and other techniques, troubleshooting and adjusting methods, data analysis and statistics, writing protocols, writing reports, documentation writing and updates, method cross-overs (method transfer), process validation testing, validation stability testing, auditing paperwork when required testing of raw materials, products, and stability program testing to BP/EP/USP.Documentation updates.Additional projects included creating a new, traceable FTIR Library, Safety Committee, Fire Warden, Standards Co-ordinator and substitute Team Leader.HPLC (Agilent with Empower2, prev. used Chemstation)GC (Agilent with Empower2, prev used Chemstation)Dissolution (manual and automatic)Titrimeter FTIRKarl FischerUVOptical Rotation Refractometer

  • Validation Chemist - Analytical

    May 2010 - Aug 2012

  • Quality Control Chemist

    Feb 2004 - May 2010
• 

  AstraZeneca

  Aug 2012 - Oct 2021

  Responsible for Method Validation, Computer System Validation, Equipment Validation, Spreadsheet Validation, Data Integrity and regulatory compliance of methods, along with management of personnel and liaising with the Validation Department to co-ordinate analytical testing of process, cleaning and revalidation. Leading a team of Analytical Chemists to ensure the smooth running of the Analytical Laboratory, including management of the timely testing and release of product, raw materials and components, validation and stability testing along with calibration and maintenance of equipment. Also responsible for overseeing Method Validation, Equipment Validation, Spreadsheet Validation and Data Integrity.

  • Analytical Technical Specialist (Team Lead)

    Dec 2015 - Oct 2021

  • Analytical Specialist / Team Leader

    Aug 2014 - Nov 2015

  • Senior Analytical Chemist

    Sept 2013 - Aug 2014

  • Analytical Chemist

    Aug 2012 - Sept 2013
• 

  ResMed

  Feb 2023 - now

  PD Support Technical Officer