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- 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.
- 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.
- Other info: Lead audits and manage junior colleagues while driving continuous improvement initiatives.
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 employer: Autolus Limited
Contact Detail:
Autolus Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Quality Assurance Specialist - QA Compliance
✨Tip Number 1
Familiarise yourself with Good Manufacturing Practice (GMP) guidelines and the specific requirements for CAR T-cell products. This knowledge will not only help you in interviews but also demonstrate your commitment to quality assurance in this specialised field.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those involved in quality assurance and compliance. Attend relevant conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in QA.
✨Tip Number 3
Prepare to discuss your experience with regulatory inspections, particularly with MHRA and HTA. Be ready to share specific examples of how you've handled audits or compliance issues in previous roles, as this will showcase your expertise.
✨Tip Number 4
Highlight your ability to work independently and manage cross-departmental relationships. Think of examples where you've successfully collaborated with other teams or led initiatives that improved quality processes, as these skills are crucial for the role.
We think you need these skills to ace Senior Quality Assurance Specialist - QA Compliance
Some tips for your application 🫡
Understand the Role: Read the job description thoroughly to grasp the key responsibilities and required skills. Tailor your application to highlight your relevant experience in quality assurance, particularly in pharmaceutical or similar industries.
Highlight Relevant Experience: In your CV and cover letter, emphasise your 2-5 years of experience in quality assurance, especially any work related to GMP compliance, CAR T-cell technology, or regulatory inspections. Use specific examples to demonstrate your expertise.
Showcase Your Skills: Make sure to mention your strong communication and teamwork skills, as well as your ability to work independently. These are essential for the role, so provide examples of how you've successfully collaborated with cross-departmental teams or managed projects.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors or inconsistencies. A polished application reflects your attention to detail, which is crucial in a quality assurance role.
How to prepare for a job interview at Autolus Limited
✨Know Your GMP Inside Out
Since the role heavily revolves around Good Manufacturing Practice, make sure you brush up on your GMP knowledge. Be prepared to discuss how you've applied these principles in previous roles and any specific experiences with compliance in a multi-product facility.
✨Familiarise Yourself with CAR T-cell Technology
Understanding CAR T-cell technology is crucial for this position. Take some time to research recent advancements and challenges in the field, and be ready to share your insights or ask informed questions during the interview.
✨Highlight Your Quality Assurance Experience
With 2-5 years of experience required, be sure to showcase your relevant background in quality assurance. Prepare examples of how you've managed quality issues, conducted audits, or improved processes in your previous roles.
✨Demonstrate Strong Communication Skills
As the role involves collaboration across departments and line management, it's essential to exhibit your communication skills. Think of examples where you've successfully built relationships or led a team, and be ready to discuss them.
