A brand-new QA Officer role has been created with a pioneering, ambitious company in Cambridge, Cambridgeshire, specialising in genomics services. This is a newly-created permanent position, paying £26k - £32k depending on experience, plus regular bonus (paid quarterly), private healthcare and excellent pension.
You will need to have a background that includes both lab-based work (routine use and development of analytical QC methods, and equipment calibration) and the processing of quality documentation, internal inspections, SOPs and ISO15189 / ISO17025 records. This will be a fantastic career opportunity, with the chance to support the company’s expansion in different countries including Germany, China and the US.
We are looking for an adaptable, energetic, collaborative, honest and versatile person to join this pioneering company who are developing new approaches to genomic research.
Your role will include:
- Organising and checking lab documents, in line with ISO17025:2017, ISO15189:2012 and GCLP regulations
- Assisting in UKAS audits and helping to ensure audit-readiness to UKAS standards
- Overseeing qualification maintenance work
- Ensuring exceptional standards for document control
- Maintaining and updating SOPs, experimental records, QMS documents, change controls and health & safety documents
- Carrying out equipment calibration according to ISO and GCLP requirements, ensuring that key equipment has been calibrated according to schedules.
- Reviewing and updating personnel training plans, carrying out staff training and carrying out quarterly competency assessments
- Ensuring that external documents are distributed and controlled according to processes, and the document status is completed before deadlines to ensure their validity
You will join a small QA team which is currently made up of 3 people and will continue to expand to support the company’s global growth. As such, this will be a fantastic career opportunity, not only to be a part of a growing a cutting-edge genomics business but also to develop your skills in QMS maintenance, document control, training, audit-readiness and continuous improvement.
Skills and Experience Required:
- Life science qualification – ideally a degree in molecular biology, biochemistry, genetics, biotechnology or similar
- A passion for Quality and developing QA / QMS processes.
- A knowledge of ISO17025 and / or ISO15189. Other knowledge such as GCLP will be highly desirable
- Being bilingual would be an advantage (though not essential), especially if you can speak German or Mandarin as well as English
- Experience in using Laboratory Information Management Systems (LIMS) and / or a Linux system would be an advantage
- Excellent communication skills and ability to work with people at all levels
- Proactive, driven, pragmatic, open-minded, emotionally intelligent, positive and respectful approach to your work
This is a permanent position which would be ideal for someone with a life science degree and some experience in QA, particularly focused on documentation and audit reports. You will be based on site in Cambridge.