QA Associate

Job Title

QA Associate

QA Manager / Senior QA Specialist

Quality Assurance – QA Operations

Full time, shift working:
Wednesday – Saturday 08:00 – 17:45

Stevenage

Our team are passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy and Autoimmune disease to deliver life-changing treatments to patients. Whilst working at Autolus you will enjoy a flexible, diverse and dynamic working environment which actively promotes creativity, leadership and teamwork – together we are ONE Autolus.

Autolus is a biopharmaceutical company, advancing innovative therapies at both clinical and commercial stages of development, focused on next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled, and highly active T cell therapies designed to better recognize cancer cells, break down their defence mechanisms, and eliminate these cells.

Autolus has a pipeline of product candidates in development for the treatment of haematological malignancies, solid tumours, and autoimmune diseases.

Our team is passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy and autoimmune diseases to deliver life-changing treatments to patients. Whilst working at Autolus you will enjoy a flexible, diverse, and dynamic working environment which actively promotes creativity, leadership and teamwork. In addition to this Autolus is proud to offer a competitive salary, performance related bonus as well as a comprehensive benefits package.

Autolus is developing complex, breakthrough therapies for a globally diverse market and equally recognises that diversity amongst our people is critical to our mission. As we draw on our differences, what we’ve experienced, and how we work, we celebrate diversity and are committed to creating an inclusive environment for all employees.

Based in Stevenage, the post-holder will work within the Quality Assurance team, supporting the delivery of autologous CAR T-cell products for commercial purposes and clinical trials operating in sites across the UK, EU and US from a central Good Manufacturing (GMP) site in Stevenage (UK). You will be expected to work with a team of quality professionals to provide a high-quality service to external service users.

• Maintaining the requirements of Good Manufacturing Practice in a multi-product facility delivering cell and gene therapies for clinical trial and commercial purposes.
• Interact with various functions to ensure cGMP compliance in batch release related activities.
• Report or escal to Line Manager any issues.
• Control of record forms for use in production and QC, applying batch or test article identity traceability features and maintaining an audit trail of issue, use and reconciliation.
• Review of Batch Manufacturing Records and Quality Control records and escalation of quality issues.
• Preparation and checking of in-process and Drug Product labels, ensuring compliance with the authorised template and the batch-specific/patient-specific data thus maintaining product traceability and regulatory compliance.
• Identify potential compliance risks/gaps and recommend improvements.
• Under supervision, review of premises and equipment documentation including logbooks, protocols, reports and equipment maintenance forms.
• To liaise with internal departments regarding quality issues when required.
• Under supervision, supports in the generation of departmental metrics.
• Conduct the archiving of documentation and records within the QA team.
• Support inspection readiness activities.
• Work in adherence to local Health and Safety policies and SOPs.
• To perform other duties which are directed by the line manager/QA Manager.
• Any other duties as required following consultation with the post holder.
• Contribute to the continuous improvement of the Pharmaceutical Quality System (PQS).
• Contribute and facilitate in quality event investigations and in the determination of root cause.