Job Description

The Quality Officer is accountable for assisting the Quality Manager in the ongoing management of all site Quality and Compliance standards to ensure site ISO accreditation.

Your responsibilities:

• Support the QA Manager in maintaining compliance of the Quality processes and documentation at Leamington Spa Megalab to meet the requirements of the Notified Bodies/UKAS.
• Support continuous improvements in the Quality Management System (QMS) at Leamington Spa Megalab.
• 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 at the Leamington Spa Megalab
• At all times, adopt a safe behavior by exercising due regard for the health and safety of yourself, colleagues and clients, in line with the Company's policies and procedures.

This represents a once in a lifetime opportunity to go above and beyond to support public health, while also extending your already accomplished technical skills and positioning your Scientific career for further success and growth.

Required Knowledge, Skills, and Abilities

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.