Quality Assurance Administrator
2 months ago
About Us
Do you want to work with a team that is changing science and enabling the next generation of genetic medicines?
The stellar growth in cell and gene therapy has accelerated the need for a better quality, faster and more robust DNA manufacturing technology.
Touchlight has created a new DNA vector for use in advanced genetic medicines that is safer and more efficacious than conventional plasmid DNA. Our unique platform also enables DNA production at unprecedented scale, speed and purity.
We believe that DNA is fundamental to the future of medicine and our CDMO has a focus on the following areas:
- Nucleic acid medicines (mRNA and DNA).
- Ex-vivo and in-vivo cell and genetic medicines.
- Gene therapy using viral vectors and gene editing.
- Autologous and allogenic cell therapy.
Role Overview
Touchlight is currently seeking a QA Administrator to join the QA department at Touchlight. The Quality Assurance Administrator is responsible for maintaining the Quality Assurance (QA) department administrative functions to maintain compliance with the Quality Management System (QMS) and demonstrating compliance through Good Documentation Practice (GMP) principles.
The Quality Assurance Administrator reports into the Quality Assurance Manager and supports the Head of Quality Assurance, as part of the QA Group. This is an operational quality role, with interactions with other departments to support on-going business needs.
The key systems in Quality Assurance for which administrative duties are required include: Client Audits, Change Control, Complaints, Continuous Improvements, Corrective and Preventive Actions, Data Integrity, Deviations, Document Control, External audits, FMEAs, Internal auditing, Laboratory Investigations, Risk Assessment, Risk Management, Root Cause Analysis, Training, Quality Events, Qualification, Self-Inspections and Validation.
Responsibilities:
- Supporting the Quality Group in their day-to-day activities.
- Maintaining and updating all electronic trackers relating to the QMS, paper records, training folders of Touchlight employees
- Issuing and reconciliation of controlled documents
- Scanning of all QMS documentation for storage and performing archiving duties
- Supporting QA activities for key Quality Management System requirements
- Review of Environmental Monitoring Program & Pest control Program and logbooks
Experience
- A degree level qualification in a biological science discipline
- Basic knowledge of working within a GMP and/or GLP environment
- Basic knowledge of Quality Management Systems
- Awareness of electronic Quality Management Systems, Quality Event management and CAPA progress
- Strong IT skills, competent Word, Excel and PowerPoint skills
- Good communication skills both verbal and written
Touchlight Benefits
Touchlight is a successful scale-up business with a record of world-leading innovation and a welcoming, entrepreneurial culture. We make Touchlight an extraordinary place to work by providing our employees with incredible facilities, flexible working and a competitive benefits and remuneration package.
A Place for Everyone
We believe diversity drives innovation and for that reason we strongly encourage those from all backgrounds to apply for roles at Touchlight. We are an equal opportunity employer and aim to build a workforce that is truly representative of the communities in which we operate and our customers.
If you need reasonable adjustments at any point in the application or interview process, please speak with the HR team who will be happy to support you.
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