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For Companies At a Glance
- Tasks: Support quality processes and maintain compliance in a cutting-edge biotech environment.
- Company: Join Portal Biotech, pioneers in protein sequencing technology.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Dynamic team atmosphere with a commitment to diversity and inclusion.
- Why this job: Make a real impact in life sciences while enhancing your quality assurance skills.
- Qualifications: Experience with Quality Management Systems and strong communication skills.
The predicted salary is between 35000 - 45000 £ per year.
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.
Quality Assurance Specialist in London employer: Portal Biotech
Contact Detail:
Portal Biotech Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Specialist in London
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching Portal Biotech and understanding their QMS processes. Tailor your answers to show how your experience aligns with their needs, especially around ISO standards and quality assurance.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or use online resources to refine your responses. Focus on articulating your experience with audits and compliance clearly and confidently.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining our team at Portal Biotech.
We think you need these skills to ace Quality Assurance Specialist in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Assurance Specialist role. Highlight your experience with Quality Management Systems and any relevant certifications. We want to see how your skills align with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance and how you can contribute to our team. Keep it concise but impactful – we love a good story!
Showcase Your Experience: When detailing your experience, focus on specific examples that demonstrate your ability to manage quality processes and support audits. We’re looking for real-world applications of your skills, so don’t hold back!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy – just a few clicks and you’re done!
How to prepare for a job interview at Portal Biotech
✨Know Your Quality Management Systems
Make sure you brush up on your knowledge of ISO 9001:2015 and any other relevant standards. Be ready to discuss how you've applied these in previous roles, especially in a regulated environment. This shows you're not just familiar with the theory but have practical experience too.
✨Showcase Your Audit Experience
Prepare specific examples of your involvement in internal and external audits. Talk about your role, what you learned, and how you contributed to the process. This will demonstrate your hands-on experience and understanding of compliance requirements.
✨Communicate Effectively
Since strong communication skills are essential for this role, practice articulating your thoughts clearly. Think about how you can convey complex quality processes in simple terms, as you'll need to train others on QMS processes. Role-playing with a friend can help!
✨Be Ready for Scenario Questions
Expect questions that put you in hypothetical situations related to non-conformance or CAPA processes. Prepare to explain how you would handle these scenarios, showcasing your problem-solving skills and ability to work under pressure.