Quality Assurance Specialist
At Quell we seek to deliver truly innovative, life-changing therapies for our patients. Our vision as a company is to build a major global biopharmaceutical company bringing transformational and valued therapies for a range of autoimmune and inflammatory diseases, as well as preventing rejection in organ transplantation, based on modular engineered Tregs.
Quell Therapeutics Ltd (“Quell”), the world leader in the development of engineered T-regulatory (Treg) cell therapies for serious medical conditions driven by the immune system, announced it has raised $156 million in an oversubscribed Series B financing. The financing round was co-led by Jeito Capital, Ridgeback Capital Investments, SV Health Investors and Fidelity Management & Research Company LLC with participation from founding investor Syncona. New investors include British Patient Capital through its Future Fund: Breakthrough program, Janus Henderson Investors, Monashee Investment Management, Point72 and funds managed by Tekla Capital Management LLC
The QA Specialist is responsible for carrying out a variety of QA activities and provides guidance and advice to key stakeholders in relation to the Quell manufacturing sites.
- Works within established processes, guidelines and methods ensuring quality guidelines are adhered to
- Support in routine QA duties to ensure manufacturing and testing activities comply with the local GMP facility processes where products are manufactured
- Day to day responsibilities include the following elements of the PQS relating to manufacture and testing of cellular therapies including;
- document control system
- training system
- change controls
- corrective and preventative actions (CAPA)
- deviation & OOS reporting
- quality risk management
- participating in internal audits
- vendor qualification
- batch record review prior to QP release
- Maintaining product specification files for ATIMP’s
- Participates in risk assessment and investigations as required
- Draft, review and approve Quality and GxP related documentation
- Provides advice and guidance to the Quell manufacturing and QC teams on Quality related issues
- Assists in the generation of quality metrics
- Highlights quality related matters or risks to others that could impact product quality, product release or regulatory compliance.
- Provides general quality support for other functions within the business e.g. R&D / clinical trial sample testing / process development teams as required
- Promote quality culture and one of continuous improvement within team
EXPERIENCE, TECHNICAL & EDUCATIONAL REQUIREMENTS
- Min 2 years’ experience or equivalent experience working in a Quality Assurance role in a GMP environment
- Experience in providing pragmatic quality advice to manufacturing and quality control functions
- Experience writing and reviewing GxP documents (including SOPs) to ensure good documentation, data integrity, GxP, quality and regulatory requirements are met.
- Working knowledge of GMP relating to sterile production, cleanrooms, aseptic technique and hygienic requirements for sterile products is desirable
- A working knowledge of regulatory requirements or processes that specifically apply for the manufacture and/or testing of cell therapy products and/or ATMP’s is required