Quality Assurance Specialist
biomodal
Date: 3 weeks ago
City: Cambridge
Contract type: Full time
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 it's 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 who want to take an active role in building out biomodal's quality systems.
Key duties:
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 13485. They should also have proved experience in equipment and methods validation, ideally in regard to hardware commonly used in laboratories. The incumbent will need to have the experience 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
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 it's 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 who want to take an active role in building out biomodal's quality systems.
Key duties:
- Internal and supplier auditing
- NCR/CAPA investigations
- Maintenance of the QMS
- Drafting quality documentation, supporting work instruction creation
- Supplier management
- Training and competence
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 13485. They should also have proved experience in equipment and methods validation, ideally in regard to hardware commonly used in laboratories. The incumbent will need to have the experience 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
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