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Quality Assurance Specialist

4 months ago


Manchester, United Kingdom Yourgene Health Full time
Job title:

Quality Assurance SpecialistnReports to : Quality Assurance ManagernLocation : Manchester Science ParknContract Type : Permanent / Full-TimenSalary & Benefits : Competitive Salary + Benefits Package

About Yourgene Health:nYourgene Health is a leading integrated technologies and services business, enabling the delivery of genomic medicine. Yourgene work in partnership with global leaders in DNA technology to advance diagnostic science.

Yourgene primarily develops, manufactures, and commercialises simple and accurate molecular diagnostic solutions, for reproductive health and precision medicine. Yourgene's flagship

in vitro

diagnostic products include non-invasive prenatal tests (NIPT) for Down's Syndrome and other genetic disorders, Cystic Fibrosis screening tests, invasive rapid aneuploidy tests and DPYD genotyping.

Yourgene has a range of innovative DNA Size Selection instruments, powered by Ranger® Technology, ideal for cell-free DNA applications in NIPT, oncology including liquid biopsy, long fragment recovery and gene synthesis applications.

Yourgene also has a global laboratory service network equipped to be a full life-cycle partner for clinical, research and pharmaceutical organisations to support partners at the preclinical, clinical, and post market stage to develop, manufacture, obtain regulatory approval and commercialise new products and services. In addition, Yourgene offers an NIPT testing service in the Manchester laboratory.

Yourgene Health is headquartered in Manchester, UK with facilities in Taipei, Singapore, the US and Canada.

Our Culture:nYourgene is a growing, vibrant and exciting place to work, we are looking for committed driven individuals to be part of our next growth journey. Our culture is described by our employee's as collegiate, friendly, professional, innovative, open and fast paced. We have plenty of social and well-being initiatives run by our Nova Social & Charity Huddle that keep our sense of community alive and allow us to be part of charity fundraisers. At Yourgene, we focus on putting values led programmes in place to ensure that we can attract, retain and develop our people. We want our people to have a career with Yourgene and we ensure that they are recognised and rewarded for their achievements and commitment, everyone plays a critical role in our growth journey.

About the role:nWe are looking to recruit a full-time and permanent QA Specialist to work within the quality assurance team based in Manchester. The QA Specialist will ensure the maintenance and continuous improvement of the company quality management system (Q-Pulse).

Key areas of responsibility:nPerform product releases by reviewing and approving products or services, ensuring they meet established quality standards.nCollaborate in the development, implementation, and enhancement of QMS documents and processes to ensure compliance with quality standards.nAssist in completing activities and maintaining records within the QMS related to Nonconformities and Corrective Actions, ensuring timely resolution and documentation.nSupport the supplier management process by evaluating suppliers, conducting audits, and ensuring adherence to quality requirements.nAssist in the management of equipment used in QA processes, ensuring proper maintenance and availability.nConduct internal audits as required to assess compliance with the QMS, identify areas for improvement, and implement corrective actions.nProvide training and support to users of the QMS, ensuring understanding and adherence to established procedures.nGenerate reports and metrics on current QA activities, evaluate the effectiveness of the QMS, and identify areas for improvement, contributing to continuous improvement initiatives.

Qualifications, Skills and AbilitiesnEssential:nHND/Graduate level or previous experience in Quality Assurance rolenUnderstanding of ISO13485, ISO15189 or ISO9001 requirementsnPrevious experience working with In Vitro Devices (IVD/IVDR) or Medical Devices (MDD/MDR)nAttention to detail/concern for impactnGood organisational and planning skills

Closing Date:nSunday 2nd June, 2024

Yourgene Health is committed to encouraging equality, diversity and inclusion among our workforce. The aim is for our workforce to be truly representative of all sections of society and for each employee to feel respected and able to give their best.