M13, Manchester, Greater Manchester
Quality Assurance Technician
Genedrive®, is an affordable, real-time PCR system that can serve as the basis for rapid detection, quantification, or drug resistance testing of infectious diseases and pathogens, such as Hepatitis C. As we further develop our Point of Care solutions through assay development and product refinement, we have an opportunity to reach millions of people who currently have limited access to existing diagnostic technology. Earlier this year, we developed Genedrive® 96 SARS-CoV-2 Kit (for PCR open platforms )to detect active infection in COVID-19 patients . Ultimately, Genedrive has the ability to change lives through the development of molecular diagnostics.
As we ramp up our focus on delivering affordable point of care in vitro molecular diagnostics for addressing global infectious disease challenges, we are looking to strengthen our Quality Team with the addition of a Quality Assurance Technician. This is a junior role within our Quality Team, reporting to our Senior QA/RA Specialist.
As a Quality Assurance Technician, you will report to the Senior Quality/Regulatory(QA/RA) Specialist and will have the following key responsibilities:
* Provide continuous maintenance and improvement of our Q-Pulse Electronic Quality Management System (EQMS)
* Provide point of need assistance for users of the EQMS across the business and be responsible for triaging any EQMS system problems with our IT support;
* Assisting the Senior QA/RA Specialist with the control of documents at all stages of the document life- cycle;
* Perform archiving duties as required;
* Produce Key Performance Indicator reports ;
* Perform Quality Inspections of Genedrive products;
* Review of Manufacturing/QC records;
* Be the Subject matter expert for employee training records on Qpulse.
* Perform other duties as assigned.
KNOWLEDGE, SKILLS & ABILITIES REQUIRED
We are looking for an individual who can demonstrate the following competencies:
* Good knowledge and understanding of Q-Pulse – our Electronic Quality Management System (EQMS) is required or alternative EQMS systems;
* Ability to work in Regulated environment;
* Good knowledge of and use of Microsoft Word, PowerPoint, Excel as required.
* Confidence and ability to generate reports analyse data and translate data into charts and graphics e.g. Key Performance Indicator ( KPI ) reports;
* Good communication skills ability to liaise with other departments across the business and interact with colleagues to complete Quality Assurance tasks on a daily basis;
* Capable of self- directed work with minimal supervision and team working;
* Ability to focus and prioritise tasks appropriately;
Must Have Experience & Qualifications:
* Must have direct experience of using Q-Pulse Electronic Quality Management Software (EQMS) gained in a medical device/IVD setting or alternatively within a pharmaceutical, health, food sectors etc or direct experience of using alternative EQMS software.
* Confident in generating data and producing reports with associated charts and graphics in respect of QA/RA team KPI’s;
* Experience of working in a Regulated environment.
* Degree in Biomedical Sciences or related discipline.
Where will I be working?
At our offices at 48 Grafton Street, Manchester within the Core Technology Facility within UMIC, which is part of the University of Manchester. Easily accessible via walking, cycling, bus and train.
Due to the nature of the role you will be required to work from our offices as the role requires you to liaise closely with our Scientists and Operations teams in situ. Our offices and laboratories are ‘Covid- Secure’. This role is not home based.
Hours of Work
You will be required to work 37.5 hours per week between the hours of 8.00am and 6.00pm. You can discuss your ideal start and finish times with us.
We provide Private Healthcare, Death in Service Benefit, Group Income Protection, Share -Option Scheme, 25 days’ holiday plus 8 statutory bank holidays per year, discretionary bonus and a Group Personal Pension scheme.
How to apply
If you would like to apply for the role of Quality Assurance Technician, please send in your CV with a covering letter to us
Previous applicants for the role of Quality Technician need not apply.
Please focus on telling us how your skills and experience match the type of person we are looking for and why you believe you would be an ideal candidate for the role of Quality Assurance Technician.
Closing Date: For internal applicants Wednesday 21st October 2020 5.00pm
No Agencies please