- Job Reference: 00064497-1
- Date Posted: 7 May 2022
- Recruiter: CV-Library
- Location: Royal Leamington Spa, Warwickshire
- Salary: £26.42 Per Hour
- Sector: Healthcare & Medical, Science & Technology
- Job Type: Temporary
A busy Laboratory based in Leamington Spa is seeking a Quality Manager. The Laboratory is part of the NHS Test and Trace Lighthouse Laboratory network and is at the heart of the UK Health Security Agency’s plans for managing coronavirus (COVID-19).
When scaled up to full capacity, the laboratory will be able to process hundreds of thousands of tests a day, adding to what is already the largest network of diagnostic testing facilities in British history. It will play an important role in stopping the transmission of COVID-19, as well as ensuring the nation can respond quickly and at greater scale to deal with pandemics and other future threats.
The site has considerable benefits to the local area in terms of job creation and putting Royal Leamington Spa on the international scientific map with world-leading technology.
Purpose of Role:
* Support Accreditation and Quality Assurance matters on site.
* Support the Head of Quality in maintaining compliance of the Quality processes and documentation on site to meet the requirements of the Notified Bodies/UKAS.
* Support continuous improvements in the Quality Management System (QMS)
* Work with the managers and their teams to maintain all aspects of the QMS e.g. Change Controls, Non Conformities, CAPAs, Customer Complaints
* Provide support as required for all Notified Bodies/UKAS and Client audits.
* Work with other QA staff to provide all the support required by the Operations teams, e.g. Work Instruction review, report review, QA statements, training, quality record review.
* Perform internal audits according to the provided schedule.
* Perform desk-based and on-site audits of sub-contractors and suppliers.
* Provide support to ensure timely release of results and audited reports to clinicians.
* Assist in training of personnel on all aspects related to the QMS.
* Support the collection and reporting of monthly Quality KPIs.
* Maintain thorough knowledge and understanding ISO 15189 requirements, Regulatory expectations and guidance documents as these pertain to the work performed on site
* At all times, adopt a safe behaviour by exercising due regard for the health and safety of yourself, colleagues and clients, in line with the Company’s policies and procedures.
Current Challenges and Opportunities:
* Support the development and implementation of a new QMS to ensure that Regulatory requirements are met whilst maximising work throughput.
* Develop and implement SOPs etc.
* Helping to train staff
* Helping to implement a "right first time" culture throughout the site
* Significant experience of operating within ISO Quality Management Systems of operational laboratory environments.
* Experience with 'Ideagen Qpulse’ Quality Management System would be a preference
* Experience in liaising with internal and external stakeholders on all areas of quality and compliance.
* Experience in conducting audits and hosting external auditors.
* Experience working within a laboratory setting working to relevant ISO accreditation standards; ISO 15189, ISO 17025, ISO 9001.
* A team player, with good analytical reasoning, customer focus, communication and change orientation in a fast paced environment