Quality Assurance Specialist

Portal Biotech; Greater London; On-site; GBP 35,000 - 50,000; Full time

Job summary

Portal Biotech is seeking a QA Specialist based in London to support their Quality Management System. The role involves managing quality documents, conducting staff training, and assisting with internal and external audits. Ideal candidates will have experience with ISO 9001:2016 standards and proven quality process support in regulated environments. Strong organizational and communication skills are essential, along with experience in electronic Quality Management Systems. Join us in our commitment to quality in the Life Sciences sector.

Qualifications

• Experience working with a Quality Management System aligned to ISO 9001:2016 or equivalent.
• Proven track record of supporting quality processes within a regulated environment.
• Practical experience participating in internal and external audits.

Responsibilities

• Manage and maintain the document management system for quality documents.
• Coordinate staff training on QMS processes.
• Support internal audits and assist during external audits.

Skills

Quality Management System

ISO 9001:2016

Internal and external audits

Communication skills

Organizational skills

Tools

MS Office

electronic Quality Management Systems

Job description

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.

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.

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 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.

Equal Opportunities

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 encourage applications from candidates of all backgrounds and experiences.