Senior Quality Assurance Specialist - QA Compliance in Stevenage

Senior Quality Assurance Specialist - QA Compliance in Stevenage

Stevenage Full-Time 42000 - 60000 £ / year (est.) No working from home possible
Autolus Limited

At a Glance

  • Tasks: Join our team to ensure top-notch quality in CAR T-cell product delivery.
  • Company: Be part of a pioneering company in cell and gene therapies based in Stevenage.
  • Benefits: Enjoy competitive pay, career growth opportunities, and a collaborative work environment.
  • Other info: Lead audits and manage junior colleagues while driving continuous improvement initiatives.
  • Why this job: Make a real impact in healthcare while working with cutting-edge technology and a passionate team.
  • Qualifications: 2-5 years in quality assurance; BSc in pharmaceutical sciences or related field required.

The predicted salary is between 42000 - 60000 £ per year.

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 Practice (GMP). The role will be based in Stevenage. Key Responsibilities Maintaining the requirements of GMP in a multi-product facility delivering cell and gene therapies Control of record forms for production and QC, ensuring traceability and maintaining an audit trail Preparation, checking, and issuing of in-process and Drug Product labels, ensuring compliance with templates and batch-specific data Review of Batch Manufacturing Records and QC records, and escalation of quality issues Authoring, approval, and review of GxP documentation Supplier management, including assessments, audits, and qualification/disqualification Materials review and release for production and QC Management of the Pharmaceutical Quality System (PQS), including change controls and deviations Continuous improvement initiatives Process and equipment qualification and validation Analytical and QC assay validation First point of escalation for issues and communication with QPs Collation and trending of Quality KPIs Supporting Product Quality Review Conducting internal audits as lead auditor Supporting regulatory inspections Line management of Junior Quality Assurance colleagues Demonstrated skills and competencies E – Essential, P – Preferred Experience 2-5 years’ experience in quality assurance within pharmaceutical or similar industries Experience with MHRA and HTA inspections Qualifications BSc in pharmaceutical sciences, immunology, or equivalent (E) MSc in pharmaceutical sciences, immunology, or equivalent (P) Skills/Specialist knowledge GMP & GCP principles Manufacturing and testing procedures for advanced therapies Understanding of CAR T-cell technology Strong communication and motivational skills Ability to build cross-departmental relationships Teamwork and accountability Ability to work independently to high standards #J-18808-Ljbffr

Senior Quality Assurance Specialist - QA Compliance in Stevenage employer: Autolus Limited

As a Senior Quality Assurance Specialist in Stevenage, you will join a dynamic team dedicated to delivering cutting-edge CAR T-cell therapies while ensuring compliance with Good Manufacturing Practice (GMP). Our company fosters a collaborative work culture that prioritises employee growth through continuous improvement initiatives and offers unique opportunities for professional development in the rapidly evolving field of advanced therapies. With a commitment to quality and innovation, we provide a supportive environment where your contributions directly impact patient outcomes.

Autolus Limited

Contact Details:

Autolus Limited Recruitment Team

StudySmarter Expert Advice🤫

We think this is how you could land Senior Quality Assurance Specialist - QA Compliance in Stevenage

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We think you need these skills to ace Senior Quality Assurance Specialist - QA Compliance in Stevenage

Good Manufacturing Practice (GMP)
Good Clinical Practice (GCP)
Quality Assurance
Batch Manufacturing Records Review
Analytical and QC Assay Validation
Supplier Management
Pharmaceutical Quality System (PQS) Management

Some tips for your application 🫡

Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Autolus Limited!

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How to prepare for a job interview at Autolus Limited

Understand the Science

Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Autolus Limited that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.

Showcase Relevant Experience

If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.

Know Their Products

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