Quality Assurance Officer
As Quality Assurance Officer, the postholders responsibility is to support the Quality Manager in the day to day upkeep of Oncologica’s Quality Management System to ensure the provision of a quality service which complies with relevant standards and which works effectively for the benefit of both Oncologica staff and the users of our service.
The Quality Assurance Officer is accountable to the Scientific Director and should notify them if they feel that the laboratory is adversely affected by any improper internal or external, commercial, financial or other pressures.
What You Do
Description of Duties:
- To assist with the maintenance of ISO15189 accreditation and in the preparation of obtaining and maintaining CLIA accreditation
- To partake in and support Oncologica’s internal and external audit schedule, including completing paperwork and reporting and feeding back to Oncologica’s Quality Manager
- To assist with audits on external suppliers against pre-set criteria and review these as appropriate
- To contribute to Oncologica’s document control system including the writing, editing, formatting, and approving of documents as required, and be involved in the control and distribution of these documents
- To assist in overseeing the upkeep of staff competencies and training
- To assist in the investigation of non-conformances and in the implementation of corrective and preventive actions
- To keep abreast of new developments relevant to the role, e.g. through attendance and participation at internal and external meetings and any relevant external training courses
- To assist in the maintenance of Oncologica’s internal asset list, and in the correct storage of associated records
- Contribute to the trending of data in preparation for Quarterly meetings amongst Senior Staff
- To partake in the minuting of senior meetings as required
- Involvement in some general operations duties i.e. stock control, ordering etc
This job description is not meant to be restrictive or exhaustive and duties may change in response to changing circumstances. These will be discussed with the post holder.
The post holder is expected to organise their own workload under direction of the Quality Manager (where needed) given the specified requirements and target deadlines.
The hours of work are 37.5; the distribution of these hours is at the discretion of the Scientific Director.
- Degree educated, ideally BSc
- Experience of working in a clinical/diagnostic laboratory
- Experience working in aspects of quality management (i.e. audits, record keeping, trending, follow through of non-conformances etc)
- Experience working in a UKAS accredited laboratory (preferably ISO15189) and experience with the UKAS audit cycle
- Experience in writing/contributing to documents of different types within a laboratory environment
- Experience in carrying out audits
- Able to interact professionally with a wide range of people including external suppliers
- Experience working with LIMS systems, databases and Microsoft Office
- Excellent organisational skills and the ability to manage and organise a diverse range of activities and to prioritise tasks effectively
- Ability to work to deadlines and respond well to an ever-changing environment
- Well-developed communication skills
- Logical and technical mindset
- Ability to problem solve
- Must be self-motivated, with a pro-active and have a flexible approach to the demands of the post
- Further education, i.e. Masters
- Additional experience of CLIA application/participation/accreditation
- Experience with QPulse software or similar