Job Description
Qkine is a Cambridge‑based biotechnology company specialising in the development and manufacture of high‑quality, recombinant, animal‑free growth factors and cytokines for research, bioprocessing, and advanced cell therapy applications. By combining proprietary production and protein‑engineering technologies, we address fundamental biological and scale‑up challenges across the stem cell, organoid, regenerative medicine, and cultured meat sectors. Our approach has enabled us to build a loyal customer base that includes leading biotechnology companies and world‑class academic institutions.
We are seeking a proactive and highly organised Quality Assurance Officer to support and maintain Qkine’s Quality Management System (QMS). This is a key role within the organisation, ensuring ongoing compliance, audit readiness, and the effective day‑to‑day operation of the QMS across the business. Quality and scientific rigour sit at the heart of everything we do, and as Qkine continues to grow, we are evolving our quality systems and processes to meet the changing needs of our customers and to support the expansion of our cell therapy product portfolio.
The successful candidate will take ownership of ISO 9001 support activities, including maintaining, controlling and administering QMS documentation through the uploading, updating and archiving of controlled documents. They will monitor and maintain employee training records to ensure ongoing compliance with QMS requirements, prepare and maintain quality documentation for Qkine products and OEM customers, and perform internal audits while supporting external audits in line with ISO 9001 requirements. Acting as the first point of contact for quality‑related queries across the organisation, this role enables the wider Quality Lead to focus on the strategic development of GMP‑aligned systems to support Qkine’s expanding cell therapy activities.
This is a hands‑on role and requires on‑site presence during the working week. The position demands very strong attention to detail, excellent organisational and communication skills, and a collaborative, practical approach to quality. We are looking for a proactive team player with a genuine can‑do attitude.
Required Experience
- Experience working with a Quality Management System (e.g. ISO 9001:2015 or ISO 13485)
- Expertise in using quality management tools and software to monitor and improve quality processes
- Ability to identify root causes of quality issues and implement effective corrective and preventive actions (CAPA)
- Strong attention to detail and a team‑oriented approach
- Knowledge of laboratory processes and/or SOP‑driven environments
- Awareness of relevant regulatory standards and compliance requirements within the biotechnology or life sciences sector
- Experience developing and delivering training programmes for quality and production staff
In addition to competitive salaries, we also offer a free private medical scheme to all our employees and an attractive employee share option scheme.
Applicants must have the right to work in the UK.
Qkine is committed to supporting and promoting equality and diversity and creating an inclusive, supportive, and flexible working environment.
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