QA Specialist

2 months ago

Stevenage, United Kingdom Autolus Full time

**Location**:

- Stevenage**Job Summary**:
We currently have an opportunity for a QA Specialists to join Autolus' growing QA function, in their QA Validation Team.

The role will see you supporting the delivery of autologous CAR T-cell production in compliance with Good Manufacutring (GMP). The role is based from our Stevenage site (hybrid working between site & remote available - approximately 2 or 3 days on site per week), working Monday to Friday 9am to 5pm.

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. Review of Batch Manufacturing Records and Quality Control records and escalation of quality 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.
- Review of premises and equipment documentation this includes; protocols, reports and equipment maintenance forms
- Management of the Pharmaceutical Quality System (PQS) including coordinating change controls, deviations, complaints, microbiological out-of-trend and out-of-specification results and other environmental excursions
- Review and qualification (or disqualification) of starting material and critical raw material suppliers, including audits and desk-based reviews
- Supplier management: Review of supplier questionnaires, approval supplier list (ASL), management of supplier management trackers. Maintain and update eQMS records for suppliers.
- Authoring, approval and review of GxP documentation
- Collation and trending of Quality KPIs
- Report or escalate to Line Manager key progress and issues.
- To perform other duties which are directed by the line manager/QA Team Lead.
- Continuous improvement of the Pharmaceutical Quality System (PQS)

  • QA Specialist

    1 month 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...

  • (Senior) Clinical QA Specialist

    1 month ago

    Stevenage, United Kingdom Autolus Ltd Full time

    **Location**: - StevenageThe (Senior) Clinical Quality Assurance Specialist is responsible for quality oversight activities within Clinical development by supporting and managing cross-functional relationships with business process owners and external stakeholders. Maintains Quality Assurance oversight in Clinical Operations and Clinical Development. This...

  • IT Service Desk Engineer Apprentice

    1 month ago

    Stevenage, United Kingdom QA Ltd Full time

    **Employer description**: Primenet UK are a Managed Services Provider and trusted IT solutions company. They offer a range of trusted IT services, from support to security to maintenance — well known for their customer service as well as their IT services. **Overview:** You will have the opportunity to gain valuable skills, knowledge and experience as...

  • QA Specialist with GMP

    1 week ago

    Stevenage, Hertfordshire, United Kingdom Nexus Jobs Limited Full time €45,000 - €50,000

    Job Description 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...

  • QA Specialist with GMP

    1 week ago

    Stevenage, Hertfordshire, United Kingdom Jas Gujral Full time €45,000 - €50,000

    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...

  • Graduate GIS Engineer

    2 weeks ago

    Stevenage, United Kingdom Candidate Source Full time

    Graduates are required to join a leading GIS company based in Stevenage. We’re offering the chance for GIS professionals of the future to be involved in the testing, development and lifecycle of desktop, server and web GIS software. Testing and evaluating software is crucial for our customers and reputation.  Graduate GIS Engineers (QA) work in...

  • Graduate GIS Engineer

    2 weeks ago

    Stevenage, United Kingdom Candidate Source Full time

    Graduates are required to join a leading GIS company based in Stevenage. We’re offering the chance for GIS professionals of the future to be involved in the testing, development and lifecycle of desktop, server and web GIS software.Testing and evaluating software is crucial for our customers and reputation.  Graduate GIS Engineers (QA) work in Quality...

  • Graduate GIS Engineer QA

    2 weeks ago

    Stevenage, United Kingdom Candidate Source Ltd Full time

    Graduates are required to join a leading GIS company based in Stevenage. We're offering the chance for GIS professionals of the future to be involved in the testing, development and lifecycle of desktop, server and web GIS software.Testing and evaluating software is crucial for our customers and reputation. Graduate GIS Engineers (QA) work in Quality...

  • Graduate GIS Engineer QA

    2 weeks ago

    Stevenage, Hertfordshire, United Kingdom Candidate Source Ltd Full time

    Graduates are required to join a leading GIS company based in Stevenage. We’re offering the chance for GIS professionals of the future to be involved in the testing, development and lifecycle of desktop, server and web GIS software. Testing and evaluating software is crucial for our customers and reputation. Graduate GIS Engineers (QA) work in Quality...

  • Graduate GIS Engineer QA

    2 weeks ago

    Stevenage, Hertfordshire, United Kingdom Candidate Source Full time

    Graduates are required to join a leading GIS company based in Stevenage. We’re offering the chance for GIS professionals of the future to be involved in the testing, development and lifecycle of desktop, server and web GIS software. Testing and evaluating software is crucial for our customers and reputation. Graduate GIS Engineers (QA) work in Quality...

  • Graduate GIS Engineer QA

    22 hours ago

    Stevenage, Hertfordshire, United Kingdom Candidate Source Full time

    Graduates are required to join a leading GIS company based in Stevenage. We’re offering the chance for GIS professionals of the future to be involved in the testing, development and lifecycle of desktop, server and web GIS software. Testing and evaluating software is crucial for our customers and reputation. Graduate GIS Engineers (QA) work in Quality...

  • Graduate GIS Engineer QA

    10 hours ago

    Stevenage, Hertfordshire, United Kingdom Candidate Source Full time

    Graduates are required to join a leading GIS company based in Stevenage. We’re offering the chance for GIS professionals of the future to be involved in the testing, development and lifecycle of desktop, server and web GIS software. Testing and evaluating software is crucial for our customers and reputation. Graduate GIS Engineers (QA) work in Quality...

  • QA Specialist

    1 month ago

    Stevenage, United Kingdom Autolus Full time

    **Location**: - Stevenage**Job Summary**: The post holder will work in the Product Delivery Quality Assurance team, supporting the delivery of autologous CAR T-cell products in compliance with Good Manufacturing (GMP). The role is based from our Cell Manufacturing site in Stevenage although hybrid working is available with 2 to 3 days a week required on...

  • Quality Assurance Specialist

    1 month ago

    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...

  • Quality Assurance Specialist

    3 weeks ago

    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...

  • Quality Assurance Specialist

    1 month ago

    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...

  • Graduate GIS Engineer QA

    2 weeks ago

    Stevenage, Hertfordshire, United Kingdom Candidate Source Ltd Full time

    Graduates are required to join a leading GIS company based in Stevenage. We're offering the chance for GIS professionals of the future to be involved in the testing, development and lifecycle of desktop, server and web GIS software.Testing and evaluating software is crucial for our customers and reputation. Graduate GIS Engineers (QA) work in Quality...

  • Graduate GIS Engineer QA

    1 week ago

    Stevenage, Hertfordshire, United Kingdom Candidate Source Ltd Full time

    Graduates are required to join a leading GIS company based in Stevenage. We're offering the chance for GIS professionals of the future to be involved in the testing, development and lifecycle of desktop, server and web GIS software.Testing and evaluating software is crucial for our customers and reputation. Graduate GIS Engineers (QA) work in Quality...

  • Graduate GIS Engineer

    2 weeks ago

    Stevenage, Hertfordshire, United Kingdom Candidate Source Full time

    Graduates are required to join a leading GIS company based in Stevenage. We’re offering the chance for GIS professionals of the future to be involved in the testing, development and lifecycle of desktop, server and web GIS software. Testing and evaluating software is crucial for our customers and reputation. Graduate GIS Engineers (QA) work in Quality...

  • Graduate GIS Engineer

    22 hours ago

    Stevenage, Hertfordshire, United Kingdom Candidate Source Full time

    Graduates are required to join a leading GIS company based in Stevenage. We’re offering the chance for GIS professionals of the future to be involved in the testing, development and lifecycle of desktop, server and web GIS software. Testing and evaluating software is crucial for our customers and reputation. Graduate GIS Engineers (QA) work in Quality...