We are looking for an energetic, open-minded and versatile individual to join a pioneering company at the forefront of synthetic and stem cell biology, manufacturing human cells for research and drug discovery purposes. Regulated to strict GMP and HTA guidelines, the company is just about to start creating a brand-new QMS, making this a perfect opportunity for you to use your range of QA skills and be part of something genuinely exciting.
This is a permanent position, paying up to £40,000 plus benefits (to be discussed on application). You will be based in the company’s modern site in Cambridge, though they have a very healthy approach towards the current Covid-19 guidelines and will accommodate you working 2-3 days a week from home (unless during HTA inspections, when you will be required on site 100%).
Reporting to the Head of QA, you will help to develop and improve Quality systems that will help the company to scale up its production of cells to support for research and drug discovery.
Your role will be broad and will include:
- Overseeing quality of manufacturing and analytics during manufacturing and testing of products, to ensure adequate and timely release of cGxP compliant products
- Writing, reviewing and approving SOPs and any other quality-related documentation (e.g. Equipment and process Validation, shipping trials and APR).
- Reviewing and approving quality systems documentation, including non-conformities, deviations, change controls, risk assessments, CAPAs etc
- Supporting quality-related customer complaint investigations and trending activities.
- Providing quality team support during customer audits and regulatory inspections.
- Ensuring that all documentation e.g. BMRs, analytical test data, reports are reviewed and approved on batch completion, and forwarded to the relevant parties for on-time batch release.
- Participating in continuous improvement initiatives to enhance working practices and to mitigate quality risks.
- Carry out internal audits as and when required.
Skills and Experience Required:
- Good qualification (BSc / MSc or similar) in a Scientific discipline
- Strong experience of Quality Assurance gained within a commercial setting, ideally in a Biologics, Cell Therapy / ATMP or Biopharmaceutical organisation, regulated to GMP and HTA standards
- Strong understanding of QMS development, CAPAs, Root Cause Analysis, Change Controls and Risk Assessments (NB. Candidates will be considered even if your experience in some of these areas is limited, provided you can demonstrate the right attitude)
- Excellent communication skills and ability to work with people at all levels
- Pragmatic, open-minded, emotionally intelligent, positive and respectful approach to your work
Full details will be provided on application. This is a permanent role in Cambridge, Cambridgeshire, paying around £40,000 (to be discussed depending on experience).