Quality Control Manager
Watford, United Kingdom
We are a friendly diagnostic veterinary laboratory and place a strong emphasis on client care and service quality. We are UKAS-accredited to the new ISO/IEC 17025:2017 standard within Biochemistry & Haematology, and provide diagnostic services in clinical pathology, microbiology and molecular biology. Our laboratory is staffed by highly trained, motivated and experienced biomedical scientists, and a veterinary team of 3 clinical pathologist and 1 internal medicine specialists.
Our clients are predominantly first opinion companion animal clinics, and the workload is interesting and varied.
We are continually expanding and developing our diagnostic service; our new Molecular Biology service has just begun, several large refurbishment projects have recently completed, and we are introducing a new LIMS system later this year.
We are seeking a Full Time Quality Manager to cover the following
- Lead the maintenance of the Quality Management System (QMS) to meet ISO 17025:2017 requirements
- Supervise the creation, maintenance and management of all QM documents
- Manage the CAPA system including root cause analysis, and analysis of trends
- Ensure laboratory staff are aware of the principles of QMS, and of the relevance and importance of their activities
- Provide QM training as appropriate to laboratory personnel
- Maintain the Quality Improvement Plan (QIP) to ensure relevant improvements to the QMS, and ensure the QMS is responsive to changes in business practices
- Act as point of contact with the accreditation authorities, including arranging and planning for the annual assessment, and maintaining the paperwork
- Schedule, carry out/supervise internal audits, monitor performance of the QM system by regular contact with all staff
- Meet with Senior Management at frequent intervals, no less than once/month and provide informal updates on progress, compliance, audit findings, and any newly identified risks. Ensure the risk and opportunities register is reviewed with the Senior Management at least quarterly
- Organise and chair the annual Management Review Meeting (MRM)
- Prepare the QMS report to include analysis of non-compliances, audit reports, external quality assurance testing and internal Quality Control programmes, validation studies and reviews of test procedures, inspections by external bodies and recommendations for improvement
- Ensure compliance of health and safety against ISO 45001 along with Senior Management
- Fulfil the duties of the Training Officer – including liaising with Section Heads to develop training programs and competency assessments for laboratory staff. Develop and maintain the accompanying documentation in compliance with UKAS requirements.
Skills and experience
- Undergraduate degree qualification in the biomedical sciences
- A postgraduate qualification in Biomedical Sciences would be an advantage
- Understanding of ISO 17025 or relevant equivalent ISO standard
- Ability to prioritise tasks; demonstrable organisational ability with proven ability to meet deadlines
- Strong attention to detail
- Effective communication skills- ability to build relationships and engage teams
- Excellent written and spoken English
- Ability to work co-operatively in a team environment on site for a minimum of 3 days per week
- A minimum of 5 years’ experience working within the biomedical science sector
- A minimum of 3 years’ experience working in quality assurance within an accredited laboratory
- Experience working within ISO 17025:2017 would be an advantage
Address: Watford, United Kingdom