Karen McAllister

Senior Regulatory Affairs Officer at BIOMED LIMITED
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Contact Information
us****@****om
(386) 825-5501
Location
Auckland, Auckland, New Zealand, NZ

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Experience

    • New Zealand
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Senior Regulatory Affairs Officer
      • Jun 2023 - Present

    • New Zealand
    • Pharmaceutical Manufacturing
    • 400 - 500 Employee
    • Regulatory Affairs Associate
      • Jan 2019 - Jun 2023

    • Documentation Specialist
      • Oct 2016 - Dec 2018

      • Update and master Specifications/Test Methods/Forms in Lims• Arrange for updated documents to be sent to Clients as required• Write Specifications and procedures for use in the Laboratory ensuring full compliance with regulatory and laboratory requirements and Pharmacopoeias• Raise CRNs to update Laboratory documents as required, prepare client responses to any questions raised in relation to the CRN. • LIMS project assistance as required• Provide copies of documents requested from departments in a timely manner• Use of SAP and Microsoft applications• Maintain documentation systems and databases on an ongoing basis to ensure adequate tracking of documentation/work lists/client information/service charges• Liaise with functional areas including NPD, NPI, QC Lab, Regulatory Affairs Show less

    • United States
    • 700 & Above Employee
    • E-commerce Website Administrator
      • May 2009 - Oct 2016

      Website Administrator • Manage company website • Content writing • Produce weekly & monthly reports • Manage website technical issues • Provide excellent customer service for all enquiries • Help create concepts for print media advertising and new products • Continuously improve product & content pages Website Administrator • Manage company website • Content writing • Produce weekly & monthly reports • Manage website technical issues • Provide excellent customer service for all enquiries • Help create concepts for print media advertising and new products • Continuously improve product & content pages

    • United States
    • Manufacturing
    • 700 & Above Employee
    • Researcher
      • Mar 2004 - Dec 2007

      • Analysis of Stability and Developmental Beauty Care Products • Method Development • Competitor product analysis • Software packages used – LIMS, TotalChrom, Chemstation • Techniques used include - HPLC/GC/UV-Vis/Viscometry/pH/SG/RI • Analysis of Stability and Developmental Beauty Care Products • Method Development • Competitor product analysis • Software packages used – LIMS, TotalChrom, Chemstation • Techniques used include - HPLC/GC/UV-Vis/Viscometry/pH/SG/RI

    • New Zealand
    • Pharmaceutical Manufacturing
    • 400 - 500 Employee
    • Senior Quality Control Analyst
      • Jan 2002 - Feb 2004

      • Training of Raw Materials Analysts• Final check of analytical documents from Analysts• Final release of raw materials for manufacture• Revision of test methods and standard operation procedures to meet pharmacopeial requirements

    • Quality Control Analyst
      • Jan 2001 - Dec 2002

      • Routine analysis of raw materials and finished drug products to GMP standards• Techniques used include FTIR/HPLC/UV-Vis, TLC, Viscosity, Hardness, Dissolution, Karl Fischer• Maintenance and calibration of laboratory instrumentation

    • United States
    • 1 - 100 Employee
    • Technical Centre Chemist
      • Jan 1998 - Dec 2001

      • Product development and formulation projects• Carry out field test programmes on new and revised technology• Provide responsive technical support services to sales, marketing and manufacturing departments• Act upon all provision of the quality system

    • Technical Centre Technician
      • Jan 1997 - Dec 1998

      • Assist in research and development programmes, field test programmes and safety programmes for Ecolab customers and staff• Undertake trouble shooting and provide assistance when problems are experienced with the process of product manufacturing• Administration and processing of test kit order and supply • Ensure supplies of all laboratory reagents and expendable supplies are adequate at all times • Ensure all laboratory equipment is maintained and calibrated

    • Quality Control Supervisor
      • Jan 1994 - Dec 1997

      • Co-Ordinate and undertake the routine testing of raw materials, line and finished product testing• Provide technical support to manufacturing• Assist staff training programmes regarding procedures and systems• Responsible for day to day running of the Quality Control Laboratory• Determine the disposition of non-conforming products• Maintain all laboratory equipment and manage calibration programme

    • Quality Control Technician
      • Jan 1989 - Dec 1994

      • Carry out routine testing of raw materials, line and finished product testing• Assist with RTA - Requests for Technical Assistance Programme and projects as directed by the Technical centre Chemist• To familiarise and act upon all provisions of the quality systems appropriate to the responsibilities of the position

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