QA Associate

Autolus Therapeutics; Stevenage; On-site; GBP 28,000 - 42,000; Full time

Job summary

Autolus Therapeutics in Stevenage seeks a QA Associate to support delivery of autologous CAR T-cell products with GMP-compliant QA processes. You will work with quality professionals to provide high-quality service to internal and external users.

Based in Stevenage, the role emphasizes cGMP batch-release activities, documentation control, and collaboration across departments to sustain audit readiness and continuous PQS improvements.

Qualifications

• Experience with GMP systems and controlled documentation (P).
• Meet requirements to work in cleanroom environment (P).

Responsibilities

• Maintaining GMP compliance in a multi-product facility for clinical and commercial purposes.
• Interact with functions to ensure cGMP compliance in batch release activities.
• Control of record forms for production and QC with batch/test identity traceability.
• Review Batch Manufacturing Records and Quality Control records; escalate issues.
• Prepare and check in-process and Drug Product labels with data for traceability.
• Identify potential compliance risks and recommend improvements.
• Liaise with internal departments on quality issues under supervision.
• Support generation of departmental metrics and archiving of records.
• Assist in inspection readiness activities and adherence to SOPs.
• Contribute to PQS and involvement in quality event investigations.

Skills

Good communications

Attention to detail

Data entry

Prioritisation skills

Decision making

Scheduling

Reliability

Team player

Multitasking

Education

Higher education

BSc in pharmaceutical services, immunology, biology, chemistry or relevant discipline

Job description

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 Associate

Reports to: QA Manager / Senior QA Specialist

Department: Quality Assurance – QA Operations

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

Location: 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 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.

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 elevate 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.

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 objectives

Autolus 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 accommodationswhereappropriate.

Autolus 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.