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For Companies At a Glance
- Tasks: Lead sterility assurance strategies and ensure high-quality sterile products.
- Company: Join OXB, a pioneer in life-changing therapies and viral vector development.
- Benefits: Competitive rewards, wellbeing programmes, and career growth opportunities.
- Why this job: Make a real impact in healthcare by ensuring product safety and quality.
- Qualifications: BSc in Microbiology or related field; experience in aseptic manufacturing required.
- Other info: Collaborative culture with state-of-the-art facilities and a focus on innovation.
The predicted salary is between 36000 - 60000 £ per year.
Overview
Join Us in Changing Lives
At OXB, our people are at the heart of everything we do. We’re on a mission to enable life-changing therapies to reach patients around the world—and we’re looking for passionate individuals who embody our core values every day: Responsible, Responsive, Resilient, and Respectful.
We’re currently recruiting for a Principal QA Specialist – Sterility Assurance. This role is crucial for maintaining compliant operations and delivering high-quality products. As the Quality technical leader, the role focuses on aseptic processing, microbiology, depyrogenation, irradiation, and sterilisation. The primary duty is to maintain sterility assurance for aseptically manufactured sterile drug and viral vector products, requiring a deep understanding of cGMP regulations and their application in aseptic production environments.
Responsibilities
- Defining, implementing, and overseeing OXB’s sterility assurance strategy, including facility design, qualification, airflow/HEPA certification, media fills, environmental monitoring, container closure integrity, and cleaning/disinfection.
- Promoting compliance with sterility assurance regulations and best practices across the business.
- Supporting aseptic manufacturing and environmental monitoring for VS and VP operations, including contamination control documentation and aseptic fill guidance.
- Leading or supporting sterility assurance investigations, risk assessments, and validation activities.
- Driving continuous improvement in sterility assurance practices, processes, and systems, including adopting new regulations and technologies.
- Managing sterility assurance audits, inspections, and supplier quality oversight, including aseptic processing CMOs.
We are looking for
- Extensive knowledge of GMP, sterile product manufacture, and pharmaceutical regulations/standards.
- BSc degree in Microbiology or related field (advanced degree preferred)
- Proven skills in influencing people using negotiation and interpersonal skills to drive through project priority tasks to ensure on-time delivery of milestones.
- Proven experience in aseptic manufacturing environments (cleanrooms, isolators, sterility test isolators).
- Strong technical expertise in sterility assurance, contamination control, and cleanroom standards, with hands-on implementation experience.
- Experience in sterility assurance validation, product validation, and supplier quality management.
- Ability to interpret worldwide aseptic/sterility regulations into practical, compliant execution.
- Experience interacting with regulatory authorities during inspections.
About us
OXB is a quality and innovation-led viral vector CDMO with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, we have more than 25 years of experience in viral vectors; the driving force behind the majority of gene therapies.
OXB collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. OXB’s world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise.
Why Join Us
- Competitive total reward packages
- Wellbeing programmesthat support your mental and physical health
- Career development opportunitiesto help you grow and thrive
- Supportive, inclusive, and collaborative culture
- State-of-the-art labs and manufacturing facilities
- A company that lives its values:Responsible, Responsive, Resilient, Respect
We want you to feel inspired every day. At OXB, we’re future-focused and growing fast. We succeed together—through passion, commitment, and teamwork.
Ready to Make a Difference?
Collaborate. Contribute. Change lives.
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Principal QA Specialist - Sterility Assurance employer: OXB
Contact Detail:
OXB Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal QA Specialist - Sterility Assurance
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend relevant events, and connect with professionals on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching OXB and understanding their core values. Be ready to discuss how your experience aligns with their mission of delivering life-changing therapies. Show them you’re not just another candidate, but someone who truly cares about their work.
✨Tip Number 3
Practice your responses to common interview questions, especially those related to sterility assurance and aseptic manufacturing. Use the STAR method (Situation, Task, Action, Result) to structure your answers and highlight your achievements.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in joining OXB and being part of their mission.
We think you need these skills to ace Principal QA Specialist - Sterility Assurance
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences that align with the Principal QA Specialist role. Highlight your knowledge of GMP, aseptic manufacturing, and any relevant certifications to catch our eye!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Share your passion for sterility assurance and how your background makes you a perfect fit for OXB. Don’t forget to mention why you resonate with our core values!
Showcase Your Achievements: When detailing your experience, focus on specific achievements in sterility assurance and quality management. Use metrics where possible to demonstrate your impact—numbers speak volumes!
Apply Through Our Website: We encourage you to apply directly through our website for the best chance of being noticed. It’s the easiest way for us to keep track of your application and ensure it gets the attention it deserves!
How to prepare for a job interview at OXB
✨Know Your Stuff
Make sure you brush up on your knowledge of cGMP regulations and sterility assurance practices. Be ready to discuss how these apply to aseptic manufacturing environments, as this will show your technical expertise and understanding of the role.
✨Showcase Your Experience
Prepare specific examples from your past work that highlight your experience in aseptic manufacturing and contamination control. Use the STAR method (Situation, Task, Action, Result) to structure your answers and make them impactful.
✨Ask Smart Questions
Come prepared with insightful questions about OXB’s sterility assurance strategy and how they implement compliance across their operations. This shows your genuine interest in the company and the role, plus it gives you a chance to assess if it's the right fit for you.
✨Demonstrate Your Soft Skills
Since the role involves influencing and negotiating with others, be ready to discuss how you've successfully worked with teams in the past. Highlight your interpersonal skills and how you’ve driven projects to completion while maintaining strong relationships.
