Location: Nottingham Salary: £25,000 – £30,000 Ref: ALS 2426Apply Here
Agenda are working in partnership with a Nottingham based life science laboratory testing facility to recruit an experienced Senior Quality Assurance Technician. During times of such uncertainty, this organisation is proud to be in a position in which they can offer permanent position security within a fast-growing team.
The focus of the position will entail taking a senior role within the quality assurance division and will focus on ensuring compliance across their various testing facilities. The role will require the successful candidate to be the driving force for driving process improvement and upholding high standards in a fast-paced environment.
As a key member of the Quality Assurance group, you will support the organisation by monitoring their various diagnostic service area in order to ensure the safety of patients is prioritised in the quality of work, that needs of customers are met and that work complies with requirements of relevant quality standards.
- Play a supporting role in the management of the QMS in accordance with the requirements of ISO 9001, ISO 15189 and Good Clinical Practice (GCP)
- Performing internal audits, reporting findings to appropriate personnel and monitoring progression of actions to ensure prompt completion through the QMS
- Assist in the production, review, and approval of all controlled documentation
- Gap analysis in accordance with agreed standards and protocols
- Assist in the maintenance of other key Quality Management System processes, for example, Non-conformance, Complaints, CAPA, Change Control, Supplier Approval, and risk assessments
- Hosting external audits
- Assist in the development and maintenance of Electronic Quality Management System (Q-Pulse)
- Assist in archiving and ensuring the integrity of the QA archive.
- Promote continual improvement of processes and services
- Identifying areas of potential issues and improvements that can be made
Duties and Responsibilities:
- A BSc degree in a relevant scientific field
- Previous experience in a scientific quality assurance/regulatory compliance-based role is essential
- Experience working with ISO 15189 or ISO 17025 QMS is essential
- Experience using of using a QMS system, preferably Q-Pulse
- Expertise in review of validations, risk assessments, performing gap analysis, identifying/raising non-conformances and change controls
- Ability to communicate effectively with team members, quality department and with internal stakeholders within the wider organisation
- Ability to manage resources effectively in a fast-paced environment
- Flexibility to travel (as-hoc) to external sites to support the organisation’s efforts across the UK