Job title: Quality Assurance Administrator
Reporting to: Senior QA Specialist
Department: GMP
No of Direct reports: 0
Location: Bristol
Summary:
eXmoor Pharma is the only integrated cell and gene therapy CDMO with over 20 years of consultancy expertise embedded across every stage of the CMC journey — from early-phase strategy to process development, GMP manufacturing and commercialisation. We provide comprehensive support across Viral Vectors, Autologous and Allogeneic Cell Therapies, and RNA technologies. This integrated model enables seamless progression from early-phase strategy through to commercial readiness.
We are looking for a Quality Administrator to support the GMP team in the maintenance of the Quality Management System and other administrative tasks. This role is a pivotal support role for the team as it will aid the compliance of the team to GMP standards.
This is an exciting opportunity to work with eXmoor’s globally recognised team of scientists, consultants, and engineers, on a wide range of Client projects in a rapidly growing market.
Job Description:
Job Purpose:
You will be responsible for the administration of the quality management system (QMS) at eXmoor. This will involve the monitoring and co-ordination of the QMS to ensure that records are being progressed in a timely manner, working with the team to progress their actions. You will be responsible for issuing all quality documentation to the GMP teams and ensuring reconciliation and archiving. Metrics and monitoring the health of the system will be a key part of the QA Administration role also, ensuring that any adverse trends are highlighted to the management team for discussion and remediation.
Main areas of responsibility/key duties:
* You will be responsible for the administration of the QMS
* You will issue quality documentation for use by the GMP team
* You will ensure documents are reconciled, receive the appropriate reviews and are archived in compliance with GMP procedures
* You will perform basic reviews of quality documentation
* You will ensure that data from the QMS is collated and trended, highlighting any adverse trends as soon as they are noted to the GMP management team
* You will collate the information required and compiling the data for quality management meetings, environmental monitoring trending reports, in-process data etc.
* You will aid the scheduling of activities within the GMP team such as external testing at contract laboratories
* You will scribe during quality meetings, possibly client meetings/audits and regulatory inspections ensuring accurate minutes and actions are taken
* You will monitor overall actions for the GMP team and aid their completion
* You will carry out other administrative tasks, as required
Person Specification:
Essential Qualifications & Experience:
* Experience of managing data, being able to collate and perform basic analysis to present the information in an understandable manner
* Experience of managing small projects, being able to organise actions into a manageable format where they can be tracked and presented to the team
* Experience of scheduling and working with external parties to organise the completion of works
* Administration tasks for a small team, enabling the timely progression of actions
* Experience of working to set standards and ways of working, understanding the importance of adhering to regulations
Desirable Qualifications & Experience:
* Experience of working in a QMS
* Experience of working in a GMP environment
Competences Required:
* Organisation, planning and time management
* Cross-team collaboration
* Facilitator
* Oral and written communication skills
* Teamworking
* Inquisitiveness, and willingness to learn
* Attention to detail and getting things finished
* Proficiency in Office365 (including Word, Excel, PowerPoint).