Job Description
Virax Biolabs UK Ltd is an innovative biotechnology company focused on immune-response detection technologies. The company is developing its flagship ViraxImmune™ profiling platform, aimed at supporting the development of in vitro diagnostic (IVD) assays for immune profiling in chronic and post-infectious conditions. In parallel, Virax Biolabs is expanding ImmuneSelect, a portfolio of products and services supporting immunology and clinical research.
We are recruiting a Quality Coordinator to join our team based at Biocity Glasgow, supporting the Quality Assurance Manager in the day-to-day operation and continuous improvement of the Quality Management System (QMS).
Key Responsibilities:
* Support the maintenance and improvement of the QMS in accordance with ISO 13485:2016 and ISO 9001:2015 requirements.
* Assist with document control activities, including the creation, revision, approval, distribution, and archiving of SOPs, work instructions, forms, and quality records.
* Coordinate internal audits, including scheduling, document preparation, and tracking of audit findings and corrective actions.
* Support external audits and inspections (e.g. notified body, regulatory, customer audits).
* Participate in the management of nonconformances, deviations, complaints, and CAPAs, including action tracking and support for root-cause analysis.
* Contribute to change control activities, ensuring that quality documentation and records are updated appropriately.
* Assist with training coordination related to quality procedures, good documentation practices (GDP), and applicable regulatory requirements.
* Support supplier quality activities, including documentation review, management of supplier corrective actions, and maintenance of supplier quality records.
* Promote a culture of quality and continuous improvement across the manufacturing and development environment.
What your background should look like:
* Degree in Life Sciences or a related discipline (or equivalent experience).
* 1-3 years’ experience in quality, compliance, or manufacturing within medical devices, pharmaceuticals, or other regulated industries.
* Basic understanding or working knowledge of ISO 13485, ISO 9001, and/or regulated quality or manufacturing environments.
* Knowledge of CAPA, risk management, or change control processes.
* Strong attention to detail and good documentation practices.
* Good organisational and time-management skills.
* Clear written and verbal communication skills.
* Willingness to learn and develop within a regulated manufacturing environment.
What Virax Biolabs Offers
We offer a competitive compensation package, designed to reward performance while supporting long-term growth and flexibility.
* Competitive base salary, aligned with experience
* Performance-based bonus structure
* Employee stock option scheme
* 28 days’ annual leave plus UK bank holidays
* Pension scheme with 6% employer and 2% employee contributions