1-3 months temporary initially
Quality Assurance specialist with a background in Biomedical Science required for a contract role with a medical testing laboratory to help set up and establish a Quality Management System for compliance with ISO 15189, UKAS and MHRA guidelines.
This will include the following:
Development of the Quality Management System including SOP’s and documents required for accreditation by UKAS on ISO 15189:2012.
Organising the laboratory for inspection readiness and responding to non-compliances and deficiencies.
Providing specialised training on the Quality Management System and Quality Management Issues and lead in the development and implementation of a coordinated training policy within the laboratory.
Ensuring appropriate risk assessments are in place.
Responsibility for the development, implementation, and maintenance of an Auditing System for the laboratory
Regularly carries out research in Quality Management to ensure the Quality Management System evolves and keeps pace with new developments.
Graduate or higher in Biomedical Science or other scientific degree accredited by IBMS.
Professional qualification in Quality would be an advantage.
Registration with the HPC desirable but not essential.
Professional experience in a medical or clinical laboratory setting, ideally in a role which involves supervising and/or training of laboratory staff.
Strong background in Quality Assurance with specific knowledge of ISO 15189 requirements and knowledge of UKAS and MHRA accreditation.
Excellent communication skills.
High level of IT competency.
Available immediately for a new position
Quality Management Systems
Medicines And Healthcare Products Regulatory Agency (Mhra) Guides