Kim Stephens

Director, Quality Assurance


Kim has over 20 years of specialised experience in bioanalysis in roles in the UK and Australia.

At Agilex Biolabs, Kim applies her expertise to the oversight of the quality management system, along with her team of Quality Auditors. She hosted a successful FDA laboratory inspection and routinely hosts NATA and Sponsor inspections assessing compliance with OECD GLP and ISO17025 and internal procedures. In recognition of Kim’s contributions to the Quality Assurance system, she was awarded BioSA’s 2011 Young Achiever of the Year Award.

As a highly regarded expert in GLP in Australia, Kim offers GLP consultancy and training to new or existing organisations. She has a passion for ongoing learning and regularly attends international conferences and is an active member of global quality professional groups. Kim has a Bachelor of Science degree with Honours.

Erika MacDonald

Quality Assurance Manager


Erika is a Quality professional, with over twenty years’ experience working in the field of pharmaceutical and API manufacturing in the UK and Australia. With a Bachelor of Science in Chemistry and Certificate IV in Competitive Manufacturing, she has expertise in Continuous Improvement of Quality Management Systems as applied to GxP processes.

At Agilex Biolabs, Erika is responsible for the Quality Assurance of the bioanalytical laboratory, encompassing clinical studies under GLP regulations to support pre-clinical and clinical release studies.

Erika is passionate about applying a risk based, continuous improvement focused approach to the Quality program while maintaining the highest Quality output.

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