At a Glance
- Tasks: Support quality and regulatory processes in a dynamic laboratory environment.
- Company: Join Guilford Street Laboratories, reshaping diagnostics with cutting-edge technology.
- Benefits: Competitive salary, career development, and hands-on experience in quality systems.
- Other info: Collaborative team culture with opportunities for growth in diagnostics.
- Why this job: Make a real impact on healthcare by ensuring quality and compliance.
- Qualifications: Degree in relevant sciences and experience in regulated environments.
The predicted salary is between 35000 - 45000 € per year.
Are you highly organised with a sharp eye for detail in regulated environments? Ready to build your career in quality and regulatory affairs while helping shape standards in a growing laboratory setting? This is an exciting opportunity to join Guilford Street Laboratories and play an important role in maintaining and improving the Integrated Management System (IMS). As a QA/RA Assistant/Manager, you will support quality, regulatory and information security processes while helping ensure compliance across laboratory operations. This role offers the chance to work closely with technical teams, strengthen your expertise and develop your career within diagnostics, healthcare and laboratory quality systems. If you are ready to take the next step in your career and join a forward-thinking laboratory team, apply today and help shape quality excellence at Guilford Street Laboratories.
Key Responsibilities:
- Support the maintenance and continuous improvement of the IMS
- Assist with compliance across ISO 15189, ISO 13485, ISO 27001, UKCA, CE, and relevant FDA/IVDR requirements
- Manage controlled documentation, including SOPs, policies, and laboratory procedures
- Support internal and external audits, including CAPA tracking
- Work alongside laboratory teams to maintain quality standards across testing and data integrity
- Assist with supplier, reagent, and service provider approvals
- Support risk management, nonconformance, and change control processes
- Maintain training and competency records
- Provide administrative support to the Quality and Regulatory department
The Company:
Guilford Street Laboratories is committed to reshaping the future of diagnostics. We apply cutting-edge machine learning to unlock better ways to detect, stratify, and monitor disease. Our values—innovation, accuracy, collaboration, empowerment, and service—guide everything we do. At Guilford Street Laboratories, your work will directly support healthcare professionals in delivering earlier and more accurate diagnoses for patients worldwide.
Benefits:
- Salary of £35,000–£45,000
- Full-time position, 35 hours per week
- Career development within a regulated scientific environment
- Exposure to leading laboratory and regulatory standards
- Supportive and collaborative team culture
- Valuable hands-on experience across quality and regulatory systems
The Person:
We are looking for a QA/RA Assistant/Manager who has:
- A degree in Biomedical Sciences, Life Sciences, Laboratory Sciences, Quality Management, Regulatory Affairs, or similar
- Previous experience within a laboratory, IVD, diagnostics, or regulated healthcare setting
- Strong knowledge of laboratory quality systems
- Excellent organisational and communication skills
- Confidence working with controlled documentation
- A real interest in diagnostics, laboratory quality, and regulatory compliance
QA/RA Assistant/Manager in Birkenhead employer: Guilford Street Laboratories
Guilford Street Laboratories is an exceptional employer, offering a dynamic and supportive work environment in the heart of Central Tech. With a strong focus on career development and exposure to leading laboratory standards, employees are empowered to grow their expertise in quality and regulatory affairs while contributing to innovative healthcare solutions. Join a collaborative team dedicated to reshaping diagnostics and making a meaningful impact on patient care worldwide.
Contact Detail:
Guilford Street Laboratories Recruiting Team
StudySmarter Expert Advice🤫
We think this is how you could land QA/RA Assistant/Manager in Birkenhead
✨Tip Number 1
Network like a pro! Reach out to people in the QA/RA field on LinkedIn or at industry events. A friendly chat can lead to opportunities that aren’t even advertised yet.
✨Tip Number 2
Prepare for interviews by researching Guilford Street Laboratories and their values. Show us how your skills align with their mission of innovation and accuracy in diagnostics.
✨Tip Number 3
Practice common interview questions related to quality and regulatory affairs. We want to see your confidence and knowledge shine through when discussing compliance and quality systems.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in joining our team.
We think you need these skills to ace QA/RA Assistant/Manager in Birkenhead
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that match the QA/RA role. Highlight any relevant experience in regulated environments and your knowledge of quality systems. We want to see how you can contribute to our mission!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality and regulatory affairs. Share specific examples of your past work that align with the responsibilities listed in the job description.
Showcase Your Attention to Detail:Since this role requires a sharp eye for detail, make sure your application is free from typos and errors. A well-organised application reflects your ability to maintain high standards, which is crucial for us at Guilford Street Laboratories.
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 shows you’re keen on joining our innovative team!
How to prepare for a job interview at Guilford Street Laboratories
✨Know Your Standards
Familiarise yourself with ISO 15189, ISO 13485, and ISO 27001 before the interview. Being able to discuss these standards confidently will show that you understand the regulatory landscape and are ready to contribute to maintaining compliance.
✨Showcase Your Organisational Skills
Prepare examples of how you've managed documentation or improved processes in previous roles. Highlighting your organisational skills will demonstrate your ability to handle controlled documentation and support the Integrated Management System effectively.
✨Be Ready for Scenario Questions
Expect questions about how you would handle audits or nonconformance issues. Think through potential scenarios and prepare your responses, focusing on your problem-solving skills and attention to detail.
✨Express Your Passion for Quality
Let your enthusiasm for quality assurance and regulatory affairs shine through. Share why you’re interested in diagnostics and how you can contribute to the company's mission of reshaping the future of healthcare.
