Senior Quality Assurance Specialist
8 months ago
**Location**:
- Stevenage**Job Summary**:
Role 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 will be based in Stevenage.
Key Responsibilities
- Maintaining the requirements of Good Manufacturing Practice in a multi-product facility delivering cell and gene therapies
- 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 Batch Manufacturing Records and Quality Control records and escalation of quality issues
- Authoring, approval and review of GxP documentation
- Supplier management: Assessment and qualification (or disqualification) of raw material suppliers, including audits; Audits of GMP contractors conducting outsourced activities; and Risk
assessments.
- Materials review and release for use in Production and QC, ensuring that only approved suppliers and materials are available
- Management of the Pharmaceutical Quality System (PQS) including coordinating change controls, deviations, microbiological out-of-trend and out-of-specification results and other environmental excursions - Continuous improvement
- Process and equipment qualification and validation
- Analytical and Quality Control assay validation
- First point of escalation issues and communication to QPs
- Collation and trending of Quality KPIs
- Support Product Quality Review
- Conducting internal audits as lead auditor in accordance with a defined schedule in a supporting capacity
- Support regulatory inspections - backroom support and/or SME support
- Line management of Junior Quality Assurance colleagues
-
Senior Quality Assurance Specialist
4 days ago
Stevenage, Hertfordshire, United Kingdom Jas Gujral Full timeJob Title: Senior Quality Assurance SpecialistEstimated Salary: £60,000 - £80,000 per annumCompany OverviewJas Gujral is a reputable organization dedicated to delivering high-quality products and services. As a leading industry player, we strive to maintain the highest standards in quality management.Job DescriptionWe are seeking a highly skilled Senior...
-
Senior Quality Assurance Specialist
3 weeks ago
Stevenage, Hertfordshire, United Kingdom Insignis Talent Full timeJob DescriptionWe are seeking an experienced Senior Quality Assurance Specialist to join our team in Stevenage.As a key member of our quality assurance team, you will be responsible for ensuring the quality and integrity of our products and services.The successful candidate will have experience in quality management systems, techniques, and processes,...
-
Quality Assurance Specialist
7 days ago
Stevenage, Hertfordshire, United Kingdom MBDA UK Ltd Full timeJob Description:We are seeking a highly skilled Quality Assurance Specialist to join our team in Stevenage. This is an exciting opportunity for a motivated individual with a passion for quality and engineering to work on high-profile projects within the defence industry.About the Role:As a Quality Assurance Specialist, you will play a crucial role in...
-
Quality Assurance Specialist
1 month ago
Stevenage, Hertfordshire, United Kingdom Copello Full timeQuality Assurance SpecialistAbout the Role:As a Quality Assurance Specialist at Copello, you will play a pivotal role in ensuring the delivery of high-quality products to our clients. You will be responsible for supporting projects across all phases of the product lifecycle, from development to delivery. This is an excellent opportunity to work with a...
-
Senior Quality Assurance Manager
2 weeks ago
Stevenage, Hertfordshire, United Kingdom MBDA Full timeJob SummaryWe are seeking a highly skilled Senior Quality Assurance Manager to join our team at MBDA. This is an excellent opportunity to leverage your expertise in quality assurance and contribute to the success of our projects.About the RoleThis role will involve providing quality assurance support to our projects, ensuring that they meet the required...
-
Senior Quality Expert
4 days ago
Stevenage, Hertfordshire, United Kingdom MBDA Full timeJob OverviewWe are looking for a Senior Quality Expert to join our Product Assurance team. As a Senior Quality Expert, you will be responsible for ensuring the quality of MBDA projects. This is a dynamic role that requires strong leadership skills and experience in Quality Assurance.Key responsibilities include overseeing the Product Assurance team, defining...
-
Senior Quality Assurance Specialist
4 weeks ago
Stevenage, Hertfordshire, United Kingdom Electus Recruitment Full timeQuality Assurance Engineer OpportunityWe are seeking a highly skilled Quality Assurance Engineer to join our team in Stevenage. As a Quality Assurance Engineer, you will play a pivotal role in ensuring the quality of our electronic equipment and preventing/minimising product non-conformance.The key responsibilities of this role include:Reviewing and...
-
Quality Assurance Engineer
7 days ago
Stevenage, United Kingdom CV-Library Full timeQuality Assurance Engineer Job Description The Opportunity: An opportunity has arisen for a Quality professional to join the Quality Assurance Programmes team. In this role, your primary responsibility will be to provide Quality Assurance support to the manufacturing team to deliver production ramp up and offload, while ensuring adherence to our...
-
Quality Assurance Engineer
4 hours ago
Stevenage, United Kingdom Electus Recruitment Solutions Full timeQuality Assurance Engineer Job Description The Opportunity: An opportunity has arisen for a Quality professional to join the Quality Assurance Programmes team. In this role, your primary responsibility will be to provide Quality Assurance support to the manufacturing team to deliver production ramp up and offload, while ensuring adherence to our...
-
Senior Product Quality Specialist
2 weeks ago
Stevenage, Hertfordshire, United Kingdom Copello Global Full timeAbout Us: As a leading global company, Copello Global is dedicated to delivering exceptional products that meet our clients' expectations.Job Summary:We are seeking an experienced Senior Product Quality Specialist to join our team in Stevenage. This role will involve supporting projects throughout the product lifecycle, ensuring core Product Assurance...
-
Electronics Quality Assurance Specialist
4 weeks ago
Stevenage, Hertfordshire, United Kingdom Electus Recruitment Solutions Full timeElectronics Quality Assurance Engineer Job DescriptionWe are seeking a skilled Electronics Quality Assurance Engineer to join our team. This role will involve working closely with the Product Assurance Equipment Engineering team to ensure the quality of electronic equipment in development.The Role:Develop and maintain equipment quality planning documentation...
-
Lead Quality Assurance Specialist
4 weeks ago
Stevenage, United Kingdom Cirrus Selection Limited Full timeLead Quality Assurance SpecialistAbout the RoleWe are seeking an experienced Lead Quality Assurance Specialist to join our Quality Supply Chain team in Stevenage. As a key member of our team, you will play a critical role in supporting non-conformance management and audit of the production supply chain, with a focus on major equipment supplier product...
-
Medical Device Quality Assurance Specialist
7 days ago
Stevenage, Hertfordshire, United Kingdom Stirling Q&R Full timeJob Title:Medical Device Quality Assurance SpecialistAbout the Role:We are seeking a detail-oriented and competent individual to join our team as a Medical Device Quality Assurance Specialist in Stirling Q&R.Responsibilities:This role combines regulatory compliance with administrative duties, ensuring our medical devices meet necessary standards and...
-
Senior Quality Assurance Specialist
8 months ago
Stevenage, United Kingdom Autolus Ltd Full time**Location**: - StevenageThe 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 will be based in Stevenage. Key Responsibilities - Maintaining the requirements of Good Manufacturing Practice in a multi-product facility...
-
Product Quality Assurance Specialist
4 weeks ago
Stevenage, Hertfordshire, United Kingdom Insignis Full timeWe are seeking a skilled Quality Assurance Specialist to join our team at Insignis, a leading organisation in the defence sector. In this role, you will support multi-national projects by ensuring the highest standards of product quality and supporting smooth equipment deliveries to meet our customers\' expectations.Key ResponsibilitiesReview and maintain...
-
Quality Assurance Specialist
3 weeks ago
Stevenage, Hertfordshire, United Kingdom Insignis Talent Full time £50,000Role SummaryWe are seeking an experienced Quality Assurance Engineer to support multi-national projects in preventing/minimizing non-conformities and ensuring smooth equipment deliveries that meet our customers' expectations.The CompanyWorld-leader in defense operations, offering a comprehensive international product range incorporating today's most advanced...
-
Aerospace Quality Assurance Specialist
2 weeks ago
Stevenage, Hertfordshire, United Kingdom Verify, Inc Full timeOverviewWe are seeking an experienced Aerospace Quality Assurance Specialist to support a full-time project on-site at a customer facility in Stevenage. The role primarily involves leading the preparation process for First Article Inspection Reports (FAIRs) using Visual FAIR, with other quality engineering tasks assigned based on project...
-
Quality Assurance Specialist
4 weeks ago
Stevenage, Hertfordshire, United Kingdom Cirrus Selection Limited Full timeQuality Assurance Role OverviewCirrus Selection Limited seeks a highly skilled Quality Assurance Engineer to join their Quality Supply Chain team. The ideal candidate will have experience working with suppliers, quality management systems, and auditing techniques.Key Responsibilities:Support non-conformance management and audit of the production supply...
-
Aerospace Quality Assurance Specialist
2 weeks ago
Stevenage, Hertfordshire, United Kingdom Verify Inc. Full timeJob OverviewWe are seeking a highly skilled and detail-oriented First Article Inspection (FAI) Engineer / Quality Assurance Specialist to support a full-time project on-site at our customer facility in the UK.The successful candidate will lead the preparation process of First Article Inspection Reports (FAIRs) using Visual FAIR, with other quality...
-
Senior Internal Auditor
4 weeks ago
Stevenage, Hertfordshire, United Kingdom M Group Services Full timeWe are seeking a skilled Senior Internal Auditor - Assurance Specialist to join our Group Assurance team, working from our Stevenage office on a part-time basis.The successful candidate will lead financial and operational audits, evaluating the effectiveness of controls and identifying themes, insights and exposures for management consideration.Key...