Quality Assurance Specialist

NIF; Greater London; Hybrid; GBP 40,000 - 56,000; Full time

Job summary

Portal Biotech in London is seeking a QA Specialist to support its Quality Management System (QMS) within the Quality Assurance & Regulatory Affairs Team at Scale Space, White City.

You will help maintain ISO 9001:2015 compliant documentation, deliver staff training, coordinate CAPA and audits, and assist Health & Safety activities, contributing to a culture of quality across the organisation.

Qualifications

• Experience with a Quality Management System aligned to ISO 9001:2016 or equivalent in Life Sciences.
• Proven track record supporting quality processes in regulated environments.
• Practical experience participating in internal and external audits.
• Proficient with electronic Quality Management Systems (eQMS) and MS Office tools.
• Interest and awareness of Health and Safety principles.
• Strong organisation and ability to manage multiple tasks to deadlines.
• Excellent communication and cross-functional collaboration across teams.

Responsibilities

• Manage and maintain the document management system ensuring ISO quality compliance.
• Deliver and coordinate staff training on QMS processes and maintain training records.
• Administer Non-conformance and CAPA processes with issue tracking and closure of actions.
• Support internal audits and assist during external audits and certification activities.
• Coordinate Health & Safety programme with the H&S lead and owners.

Skills

QMS experience

Audits

Health & Safety awareness

Cross-functional collaboration

Organisational skills

Tools

eQMS

MS Office

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.

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.