Quality Assurance Specialist

5 months ago

Oxford, United Kingdom Oxford Nanopore Technologies Full time

Oxford Nanopore Technologies is headquartered at the Oxford Science Park outside Oxford, UK, with satellite offices and a commercial presence in many global locations across the US, APAC and Europe.

Oxford Nanopore's sequencing platform is the only technology that offers real-time analysis, in fully scalable formats from pocket to population scale, that can analyse native DNA or RNA and sequence any length of fragment to achieve short to ultra-long read lengths. Our goal is to enable the analysis of any living thing, by anyone, anywhere

We are looking for a highly motivated individual to join the Quality Assurance team as a Quality Assurance Specialist. This exciting and challenging role is responsible for providing Quality Assurance/regulatory guidance to the business and supporting Quality Management System development and maintenance and New Product Introduction.

We are looking for a highly motivated individual to join the Quality Assurance team as a Quality Assurance Specialist. This exciting and challenging role is responsible for providing Quality Assurance/regulatory guidance to the business and supporting Quality Management System maintenance and development and New Product development..

This position has a significant impact on the success of ONT business processes. This role will improve our ability to meet customer expectations and improve quality and compliance

**The Details.**
- Support the maintenance of Quality System documentation in line with the ONT Quality System
- Review and approve Change Control documentation for Quality Assurance
- Analyse and communicate proposed, new or changing requirements
- Review and approve Non-conformance and CAPA documentation
- Provide support to routine manufacturing activities, projects, development and training
- Provide system support, guidance and training in relation to the Document Management System
- Provide support to New product development activities and processes
- Participate in Risk Management activities
- Perform area walkthroughs, internal and external audits
- Support the development and maintenance of Quality System metrics
- Support the preparation and execution of Management Reviews
- Support qualification/validation activities in relation to equipment, processes and/or computer systems
- Identify and report any quality or compliance concerns and take immediate corrective action as required

**What We're Looking For.**

A minimum of 2 years of working in a Quality Assurance role with a good background in ISO 9001

Knowledge of and experience of working in an ISO 13485 environment is advantageous

Excellent working knowledge of Document Management Systems, Change Control, CAPA systems and Root Cause Investigation tools

Close attention to detail and ability to handle multiple priorities effectively

Good team player with customer focus, demonstrating a sense of urgency to resolve issues as they arise

Able to evaluate situations, identify options and propose effective solutions with rationale quickly and efficiently

Highly self-motivated person with excellent communication, organisational, problem solving and negotiation influencing skills

Be highly collaborative and able to work in a fast-paced, team-based environment

Excellent interpersonal/written communication skills; can interact effectively with all levels of management and with team members of different technical and business areas.

Experience of ERP systems, Bills of Materials.

We offer outstanding benefits to include an attractive bonus, generous pension contributions, private healthcare and an excellent starting salary. Based within beautiful, landscaped surroundings with tree-lined walks, water features and a lake, all of which make for a wonderful working environment.

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Oxford Nanopore's goal is to bring the widest benefits to society through enabling the analysis of anything, by anyone, anywhere. The company has developed a new generation of nanopore-based sensing technology enabling the real-time, high-performance, accessible and scalable analysis of DNA and RNA. The technology is used in more than 100 countries to understand the biology of humans and diseases, plants, animals, bacteria, viruses and whole environments.

Oxford Nanopore was founded in 2005 as a spin-out from the University of Oxford and now employs over 1000 employees around the world.

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