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Tempus Personnel
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Manchester, Greater Manchester
QC Assistant
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Job Type: Full-time |
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Overview
Company Profile Yourgene Health is an international molecular diagnostics group which develops and commercialises genetic products and services. The group works in partnership with global leaders in DNA technology to advance diagnostic science. Our commercial footprint is already established in the UK, Europe, the Middle East, Africa and Asia. Through our technical expertise and partnerships, Yourgene Health is aiming to extend its genetic testing offering into complementary areas of reproductive health and oncology. At Yourgene Health we pride ourselves in our culture and performance of our people. We live by our values and behaviours. We set annual global business goals which cascade down to departmental goals and individual employee goals to support the performance of not just the business but our employees who contribute towards our success. We are a global business with locations in Manchester, Taipei, India, Singapore and most recently the US. QC Assistant Manufacture and Quality Control release of Yourgene Health products. Contribution to design, development, validation and improvement of processes as required. Overall Responsibility To ensure that Yourgene Health products are Quality Control released correctly, cost effectively and delivered on time in accordance with specification and quality requirements. Includes manufacture and subsequent QC release of reference standards and run control materials. Run control materials are included as components of IVD products manufactured by Yourgene Health. Key areas of responsibility: Responsible for execution of all Quality control processes for IVD products manufactured by Yourgene Health in order to achieve on time delivery targets cost effectively. Responsible for executing of all stability studies required to support Yourgene Health products. Completion of Device Manufacturing Records used to document Quality Control activities in line with ISO13485 requirements. Communicating with appropriate departments to ensure product release is performed on time achieving delivery targets. Flagging of any potential delaying factors at an early stage. Raising non-conformities as appropriate and implementing corrective and/or preventative actions as identified through the CAPA process. All activities performed to a high standard of quality assessed through the number of non-conformity records and ensuring consistent pass rates. Liaising with Supply Chain functions to ensure material is purchased cost effectively and available for testing when required. Managing stock control/inventory activities to ensure raw material and product is appropriately goods receipted, located, stored and transferred correctly throughout the process. Ensure own work meets regulatory and quality requirements (including compliance to SOP’s, documentation using lab books, study plans, study reports and integrity of data). General lab maintenance and upkeep including arranging the preventative maintenance and calibration of certain key pieces of instrumentation. Perform verification activities when required. Qualifications, Skills and Abilities Expertise and experience in the manufacture and/or Quality Control release of molecular diagnostic assays in adherence with ISO13485 Quality Management Systems and/or CE marking. Thorough understanding of Quality Management Systems. Hands on experience with molecular based assays (ideally using next-generation sequencing technologies although not essential). Be expert in dealing with, and efficient in processing paperwork. Enthusiasm, drive, thoroughness, diligence and a willingness to take personal responsibility to ensure that projects are successful. Good organisational skills and enjoys working to tight timelines. Good IT Skills, including Microsoft Office Suite. Benefits Private Health Care of BUPA Cash Plan. 5X Death in service. Discretionary Bonus. 25 days holiday which increases by one day each year up to a maximum of three years. Plus 8 Bank holidays. 1 additional days holiday for your birthday, to be taken in the week of your celebration. As an employee's time in service and accountability increases, as do the benefits. Should this be applicable this would be discussed at interview.