Quality Assurance Specialist

Oxford Nanopore Technologies (ONT) develops and manufactures innovative nanopore-based sequencing technologies for global research biopharma and IVD markets. Operating under ISO 13485 and ISO 9001 quality management systems ONT ensures compliance with global regulatory requirements.

A sub-team of the QARA department the Quality Systems team is responsible for ensuring that systems and processes are integrated across all departments and projects promoting consistency and continuous improvement across the firm.

The Quality Assurance Specialist is responsible for the review and approval of key quality system records and activities within the Quality Management System (QMS) ensuring compliance with internal procedures and applicable regulatory standards (including ISO 13485 and ISO 9001).

In addition the role is accountable for driving end-user adoption and effective utilisation of the companys electronic QMS (eQMS) and for increasing quality awareness across the organisation. The post holder will lead initiatives to improve engagement understanding and consistency in the application of quality processes.

The role acts as a quality gatekeeper QMS adoption lead and quality culture champion providing both operational oversight and organisational influence.

Key Responsibilities

Quality Event Review and Approval

• Review and approve Change Control and Deviation requests Nonconformance reports CAPA records

• Critically assess Root Cause Analysis Risk Assessments proposed corrective and preventive actions

• Ensure timely progression and closure of quality events

• Escalate significant quality or compliance risks

eQMS Adoption and User Engagement

• Act as the lead for end-user adoption of the eQMS (e.g. MasterControl)

• Develop and maintain training materials user guides and support resources

• Deliver or coordinate training to drive effective system use

• Design initiate and manage user feedback mechanisms (e.g. surveys)

Quality Awareness and Culture Development

• Lead initiatives to increase quality awareness across the organisation

• Plan and organise Quality Week and engagement events

• Develop and streamline GxP training materials to improve accessibility and effectiveness

• Draft and deliver QA communications updates and newsletters

QA SharePoint and Knowledge Management

• Own and manage the QA SharePoint site as a central hub for quality communication and resources

• Maintain and update content for organisation-wide audiences (e.g. newsletters announcements awareness content) and internal QA users (e.g. quality records guidance process resources)

• Ensure content is accurate structured accessible and kept up to date

• Continually improve site usability and effectiveness as a communication and knowledge platform

Other

• Identify and report any quality or compliance concerns

• Be aware of and comply with the Quality Manual Quality Management System Quality Policy Quality Goals and applicable regulations as they apply to this job type/position

• Provide QA guidance and constructive challenge to ensure compliance

• Influence behaviours and promote best practices across the organisation

• Provide expert guidance to stakeholders on QMS processes

• Any other duties as might be required within the remit and responsibilities of the post