QA Associate

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 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

Equal Opportunity Employer

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.

Data Protection

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).