Job title: Quality Assurance Specialist Reports to: Quality Assurance Manager Location: Manchester Science Park (M15 6SH) Contract Type: Full-time, Permanent Salary & Benefits: Competitive Salary Benefits Package About Yourgene Health: Yourgene Health is a leading integrated technologies and services business, enabling the delivery of genomic medicine. The group works 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, precision medicine and infectious diseases. The Group'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 sample preparation platforms, powered by Ranger Technology, the Yourgene LightBench and Yourgene QS250, ideal for cell free DNA applications in NIPT and oncology including liquid biopsy. 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 and NIPT and high throughput Covid testing service. Yourgene Health is headquartered in Manchester, UK with facilities in Taipei, Singapore, the US and Canada. Our Culture: Yourgene 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 nay social and well-being initiatives run by our Social Huddle that keep our sense of community alive during challenging times that the pandemic has thrown our way. 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. Description of role: Yourgene Health, part of Novacyt Group are recruiting for a Quality Assurance (QA) Specialist. The Quality Assurance Specialist will work within the QA team to ensure the maintenance and continuous improvement of the company Quality Management Systems (QMS). Key areas of responsibility: Perform product releases by reviewing and approving products or services, ensuring they meet established quality standards. Collaborate in the development, implementation, and enhancement of QMS documents and processes to ensure compliance with quality standards. Assist in completing activities and maintaining records within the QMS related to Nonconformities and Corrective Actions, ensuring timely resolution and documentation. Support the supplier management process by evaluating suppliers, conducting audits, and ensuring adherence to quality requirements. Assist in the management of equipment used in QA processes, ensuring proper maintenance and availability. Conduct internal audits as required to assess compliance with the QMS, identify areas for improvement, and implement corrective actions. Provide training and support to users of the QMS, ensuring understanding and adherence to established procedures.
Generate 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 Abilities: HND/Graduate level or previous experience in Quality Assurance role Understanding of ISO13485 Previous experience work in In Vitro Devices or Medical Devices Attention to detail/concern for impact Good organisational and planning skills Good communication skills Closing Date: Sunday 29th September, 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.