QA Associate

3 weeks ago


Stevenage, United Kingdom Autolus Full time

**Location**:

- Stevenage**Job Summary**:
The QA Associate will work within the Quality Assurance team, supporting the delivery of autologous CAR T-cell products for clinical trials operating in sites across the UK, EU and US from a central Good Manufacturing (GMP) site in Stevenage (UK) and headquarters in White City, London. You will be expected to work with a team of quality professionals to provide a high-quality service to external service users.

Please note these are fully on site, shift based roles. You will work either Sunday to Wednesday or Wednesday to Saturday; 8am to 5.45pm.

Some of the duties include:

- Maintaining the requirements of Good Manufacturing Practice in a multi-product facility delivering cell and gene therapies for Clinical trials
- Interact with various functions to ensure cGMP compliance in batch release related activities.
- You will collaborate within site and/or inter-site stakeholders to ensure batch release requirements are met.
- Report or escalate to Line Manager key progress and issues.
- Preparation, checking and issue 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.
- Identify improvement in quality processes.
- To liaise with Production and Quality Control departments with regard to quality issues when required.
- To perform other duties which are directed by the line manager/QA Team Lead.
- Continuous improvement of the Pharmaceutical Quality System (PQS)


  • Senior QA

    4 weeks ago


    Stevenage, United Kingdom BioTalent Full time

    I have an exclusive opportunity for a **Senior QA Associate** to join a pioneering biotechnology company based in **Stevenage** that focuses on developing T-cell therapies for cancer treatment. They seek a Senior QA Associate with GMP experience to support their manufacturing site and ensure compliance with regulatory requirements for clinical trial...

  • QA Specialist

    3 weeks ago


    Stevenage, Hertfordshire, United Kingdom Nexus Jobs Limited Full time

    QA Specialist - Project Support - 12 month Fixed Term Contract Our Client is looking to recruit a QA Specialist with at least 5 to 10 years expertise within a clinical environment. Reporting to and with the guidance of the Head of Quality Assurance, this role will ensure that the manufacturing centre, via proactive engagement, meets the standards and...


  • Stevenage, Hertfordshire, United Kingdom Blackfield Associates Full time

    Blackfield Associates is currently assisting a leading clinical-stage biopharmaceutical company in their search for a Senior Quality Assurance Specialist based in central Stevenage. As the Senior Quality Assurance Specialist, you will be responsible for executing QA tasks to ensure compliance with local GMP facility processes during manufacturing and...


  • Stevenage, Hertfordshire, United Kingdom Blackfield Associates Full time

    Blackfield Associates is currently assisting a leading clinical-stage biopharmaceutical company in their search for a Senior Quality Assurance Specialist based in central Stevenage. As the Senior Quality Assurance Specialist, you will be responsible for executing QA tasks to ensure compliance with local GMP facility processes during manufacturing and...


  • Stevenage, Hertfordshire, United Kingdom Blackfield Associates Full time

    Job Description Blackfield Associates is currently assisting a leading clinical-stage biopharmaceutical company in their search for a Senior Quality Assurance Specialist based in central Stevenage. As the Senior Quality Assurance Specialist, you will be responsible for executing QA tasks to ensure compliance with local GMP facility processes during...

  • QA Team Lead

    1 week ago


    Stevenage, United Kingdom Rentschler Biopharma SE Full time

    Rentschler Biopharma ist ein führendes Auftragsentwicklungs - und Produktionsunternehmen (CDMO) für Biopharmazeutika. Am Hauptsitz in Laupheim, Deutschland, sowie einem zweiten Standort in Milford, MA, USA, bieten wir Full-Service Lösungen für die Bioprozessentwicklung und die Herstellung hochwertiger Biopharmazeutika sowie damit verbundene...

  • LIMS Administrator

    3 weeks ago


    Stevenage, United Kingdom Autolus Limited Full time

    Role Summary LIMS Administrator (LIMS Admin) provides administrative and developmental support to the STARLIMS system within Quality Control. LIMS Admin is responsible to ensure compliance with the technical and operational aspects of the LIMS. Job holder is acting as SMEs for troubleshooting of the live system. Job holder establishes effective...


  • Stevenage, United Kingdom Redwood Publishing Recruitment Full time

    We have a lovely new role working for a prestigious Membership organisation, who are looking to recruit an Assistant Digital Editor to work within their all-important Academy, where digital learning is a key part of the of the organisation’s Skills and LearningNetwork strategy, and this role is key to the deliver this provision. The Assistant Digital...

  • Construction Manager

    3 weeks ago


    Stevenage, United Kingdom Mace Full time

    The opportunity We are hiring an ambitious and forward-thinking construction manager MEP/ - Electrical to join our established and growing team in London and Stevenage. Your Responsibilities Will Include ·Responsible for managing the construction delivery of MEP services on projects to the agreed outcomes for time, budget, safety and quality...

  • Construction Manager

    3 weeks ago


    Stevenage, Hertfordshire, United Kingdom Mace Full time

    The opportunity We are hiring an ambitious and forward-thinking construction manager MEP/Construction Manager - MEP/ Electrical Biased Technical Services Manager - Electrical to join our established and growing team in London and Stevenage. Your Responsibilities Will Include· Responsible for managing the construction delivery of MEP services on projects to...


  • Stevenage, United Kingdom Bulletproof Full time

    **Who You Are / Your Next Challenge** Bulletproof, an innovative and expending Cyber Security specialist, is looking to recruit a Senior Penetration Tester, to join our growing team in the UK. As our Penetration Tester and Red Team Specialist, with a focus on infrastructure testing, you will perform formal and comprehensive penetration testing assessments...

  • Construction Manager

    4 weeks ago


    Stevenage, United Kingdom Mace Full time

    The opportunity   We are hiring an ambitious and forward-thinking construction manager MEP/Construction Manager - MEP/ Electrical Biased Technical Services Manager - Electrical to join our established and growing team in London and Stevenage.     Your Responsibilities Will Include ·       Responsible for managing the...