Quality Assurance Specialist

biomodal; Cambridge; On-site; GBP 40,000 - 70,000; Full time

Job summary

An innovative life sciences technology company is seeking a Quality Assurance Specialist to ensure compliance with key quality standards. In this role, you will play a pivotal part in developing the company's quality management systems while working in a dynamic environment. With a focus on both research use and diagnostic applications, your expertise in ISO 9001 and ISO 13485 will be crucial. This is a unique opportunity to contribute to a cutting-edge organization poised for significant growth and impact in the biotechnology sector. Join a passionate team dedicated to advancing health and disease understanding through multiomics!

Benefits

Annual company bonus

25 days leave

Private healthcare

Life insurance

Great onsite amenities

Qualifications

• Experience in Quality Assurance within biotechnology/life sciences.
• Familiarity with ISO 9001 and ISO 13485 standards.

Responsibilities

• Conduct internal and supplier audits to ensure compliance.
• Maintain and develop the Quality Management System.

Skills

Quality Assurance

ISO 9001

ISO 13485

Auditing

NCR/CAPA investigations

Supplier Management

Education

Degree in Life Sciences

Certification in Quality Management

Tools

Quality Management System (QMS)

Laboratory Equipment Validation

Job description

About Biomodal

Join the multiomic revolution! Over the last 20 years, genomic technologies have enabled significant discoveries that bring the promise of personalised medicine closer than ever before. But after two decades of research, it's clear that genetic variation only tells part of the story – biology is dynamic and more complex than A, C, T, G. Already, the added information from a multiomic view of biology is yielding important insights into cancer, ageing, and neurological disease, and is poised to revolutionise how we understand health and disease beyond canonical variation in DNA.

Biomodal is an omics-based life sciences technology and analytics company, delivering products that bring the dynamism of our ever-changing biology into focus. Our team is dedicated to developing the most advanced solutions to interrogate and understand the complex interplay of genomics and epigenomics.

We have launched our first products, the duet +modC and duet evoC solutions, with more in the pipeline, and are looking to grow and evolve our business accordingly. This is an incredible opportunity to step into an exciting, early-stage company at the cutting edge of science with exceptional growth and market impact potential.

Multiomics is the future – come and join the biomodal team!

The Team

The Manufacturing & Operations function is a multi-disciplinary team whose remit is to support biomodal's ability to scale and drive the efficient production and distribution of its products. Encompassing, Quality, Logistics, Manufacturing and Project Management, the team is a critical part of biomodal's evolution from a start-up technology company to fully a fledged SME.

The Role

As a Quality Assurance Specialist, you will be responsible for ensuring biomodal's development and manufacturing activities meet the necessary compliance and quality standards. Our products span both RUO and potentially diagnostic applications and hence fall under ISO 9001 and ISO 13485, so require a strong quality management system (QMS) with rigorous auditing and ongoing development. Biomodal is currently developing its own in-house manufacturing capabilities, which is creating new opportunities to further develop our core QMS and affiliated work processes. This is a work in progress, so we are seeking individuals who enjoy being in a dynamic environment and want to take an active role in building out biomodal's quality systems.

Key duties:

1. Internal and supplier auditing
2. NCR/CAPA investigations
3. Maintenance of the QMS
4. Drafting quality documentation, supporting work instruction creation
5. Supplier management
6. Training and competence

The Person

The ideal candidate will have direct experience as a Quality specialist within the biotechnology/life sciences sector. This experience could have come from medical devices, pharmaceuticals, diagnostics or research tools sectors, but this experience should have encompassed ISO 9001 and ideally ISO 13485. They should also have proven experience in equipment and methods validation, ideally in regard to hardware commonly used in laboratories. The incumbent will need to be autonomous in their day-to-day activities and be willing to drive a quality-mindset through the business by being a valued and credible business partner.

Benefits

• Annual company bonus
• 25 days leave
• Private healthcare and life insurance
• Great onsite amenities

Great in-office benefits, friendly and collegial working environment, beautiful technology park location and exciting laboratory/technology focused industry sector.