QA Associate

Autolus, Inc.; Stevenage; A distancia; GBP 28.000 - 40.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Private medical insurance

Life insurance

Pension

Employee share scheme

Flexible working

Descripción de la vacante

Autolus, Inc. in Stevenage is seeking a QA Associate to join the QA Operations team. The role reports to the QA Manager/Senior QA Specialist and involves working in a multi-product GMP facility, supporting batch release, documentation, and regulatory compliance for autologous CAR-T products.

You will interact with cross-functional teams, maintain cGMP, ensure traceability, and contribute to continuous improvement of the PQS while supporting inspection readiness and safety policies.

Formación

• Experience with GMP systems and controlled documentation.
• Cleanroom environment requirement.
• Bachelor-level degree in pharmaceutical sciences or related field.

Responsabilidades

• Maintain GMP compliance in QA operations to support batch release.
• Review documentation to ensure traceability and regulatory compliance.
• Support inspection readiness activities and audits.
• Collaborate with QA team to investigate quality events and root causes.

Conocimientos

GMP systems

Cleanroom

Communications

Attention to detail

Data entry

Time management

Team player

Educación

BSc in pharmaceutical sciences or related field

Descripción del empleo

## QA AssociateApply: UK - Stevenage: Full time: Posted Today: JR100175**Work with us** 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.**Job Description:**Job Title: QA AssociateReports to: QA Manager / Senior QA SpecialistDepartment: Quality Assurance – QA OperationsHours: Full Time (shift based), Sunday – Wednesday 08:00 – 17:45Location: Stevenage **About 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. **Why Autolus**Our team is passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy 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 private medical insurance, life assurance, pension and access to an employee share scheme. Autolus promotes flexible working. **Our Promise**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 **Role Summary**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. **Key Responsibilities*** 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 escalate 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 Team Lead.* 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. **Demonstrated skills and competencies** **E – Essential****P – Preferred** **Experience*** Experience working with GMP systems and controlled documentation (P).* Meet requirements to work in cleanroom environment (P). **Qualifications*** Higher education (P)* BSc in pharmaceutical services, immunology, biology, chemistry or relevant discipline (P) **Skills/Specialist knowledge**The post holder will bring expertise related to:* Good communications skills* Good eye for detail* Accurate data entry skills* Good workload prioritisation skills, decision-making and scheduling skills* Reliability, flexibility, motivation and a responsible team-orientated attitude* Ability to manage multiple activities to tight deadlines **Autolus Core Competencies** **Focus on Results:** Works to meet business goals set by management and leaders **Builds Trust and Relationships:** Ensures trust with internal and external partners by delivering on commitments **Resilience:** Has the capacity to recover quickly from difficulties; toughness **Communicates and Collaborates:** Builds partnerships and works collaboratively with others to meet objectivesAutolus is committed to the protection of the personal information that we collect & process and we are fully compliant with General Data Protection Regulations (GDPR).Autolus is committed to providing an inclusive and fair workplace for all. We are an equal opportunity employer and do not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected characteristic. We also provide reasonable accommodations throughout the recruitment process.Autolus’ success is driven by equality and inclusion; we believe all voices are of equal value and must be heard. Whilst operating with focus and integrity, we are committed to improving diversity and inclusion within our business and our industry.