Quality Assurance Specialist

Quality Assurance Specialist We are seeking a Quality Assurance Specialist to support ongoing compliance, maintain effectiveness and to help continually improve our Quality Management System. We usually respond within two weeks About Us: Portal Biotech has built the world’s only platform capable of sequencing full-length proteins at the single-molecule level. Using our nanopore technology, we read intact proteins of any size, capturing both sequence and post-translational modifications in a way no other system can. This opens up entirely new ways to understand protein biology, with applications across drug discovery, diagnostics, and biosecurity. Our technology works and customers are engaging. We’re now focused on scaling, turning breakthrough science into products that deliver real biological insight as we move beyond Series A towards global product launch. Position Overview: We are seeking a QA Specialist to support our Quality Management System (QMS) as part of our Quality Assurance & Regulatory Affairs Team, based at our headquarters in Scale Space, White City, London. The role provides an exciting opportunity for a Quality Professional to gain further exposure to quality processes while using existing skills to support ongoing compliance, maintain effectiveness and to help continually improve our Quality Management System. The role holder will be able to make a real impact to a developing Quality Management System and the culture of quality at Portal Biotech. Key Responsibilities: Manage and maintain the document management system, ensuring all quality documents are compliant with ISO 9001:2015 requirements. Deliver and coordinate staff training on QMS processes, ensuring employees are equipped with the knowledge they need and that training records are accurately maintained. Administer the Non-conformance and CAPA processes, including tracking issues, investigation support, and ensuring timely closure of actions. Support the planning, coordination, and execution of internal audits, and assist during external audits and certification activities. Coordinate and support the Health & Safety programme, liaising with the H&S competent person and applicable internal duty/task owners. Essential Requirements: Experience of working with a Quality Management System (aligned at a minimum to ISO 9001:2016 or equivalent) ideally within the Life Sciences sector. Proven track record of supporting quality processes within a regulated environment. Practical experience participating in internal and external audits. Proficient in the use of electronic Quality Management Systems (eQMS) and standard IT tools (e.g. MS Office). An interest and awareness of Health and Safety principles. Good organisational skills, with the capability to plan and complete multiple tasks to defined timelines while balancing priorities. Strong communication and collaboration skills, enabling effective work across cross-functional teams and engagement with stakeholders at multiple levels of the organisation. Desirable Requirements: Experience of working with a Quality Management System in accordance with ISO 13485:2016 Knowledge of medical device hardware and software standards and regulations (e.g. ISO 14791 ISO 62304 & FDA QSMR). Lead or Internal Auditor certification (e.g. IRCA/CQA) Health and Safety certification (e.g. IOSH Managing Safety) or equivalent practical experience. Portal is an equal opportunities employer. We are enriched by our diversity and are committed to creating and sustaining an inclusive and equitable environment for all. We are a values-led company, and the dedication, passion, and enthusiasm of our talented employees is our cornerstone. We strive to create an environment where our team feels empowered to be their best selves, and where they enjoy working and building both the technologies and our company with us. We encourage applications from candidates of all backgrounds and experiences. Team QA/RA Locations London Remote status Hybrid About Portal Biotech Founded by DNA-sequencing veterans, Portal Biotech is developing the first bench-top single-molecule protein sequencer, leveraging machine-learning algorithms and building on decades of in-house expertise in nanopore technology. By analysing full-length protein molecules at the single-molecule level, our platform delivers rapid, real-time information on protein identity, abundance, and structure. Those insights open frontiers in drug discovery, diagnostics, and fundamental research, helping scientists and clinicians to better understand human health and disease. Founded in 2021