At a Glance
- Tasks: Ensure quality oversight of raw materials in a dynamic production environment.
- Company: Join OXB, a leader in life-changing therapies and innovative viral vector solutions.
- Benefits: Enjoy competitive rewards, wellbeing programs, and career development opportunities.
- Other info: Collaborative culture with state-of-the-art facilities and a focus on growth.
- Why this job: Make a real impact in the pharmaceutical industry while working with cutting-edge technology.
- Qualifications: Bachelor’s degree in Life Sciences and 7 years of relevant experience required.
The predicted salary is between 60000 - 80000 £ per year.
Join Us in Changing Lives
Location: on-site role, Durham, NC
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. Following the expansion of our US footprint with the acquisition of a new commercial-scale viral vector facility in Durham, North Carolina we have some new opportunities to join us. We’re currently recruiting for a Quality Assurance Specialist, Raw Materials, to join our team. In this role, you will be providing quality oversight of activities supporting the end-to-end production process in accordance with OXB policies, standards, procedures and cGMP, playing a key part in advancing our mission and making a real difference.
Your responsibilities in this role would be:
- Lead risk assessments and author technical reports for new raw material enrolment and open-container expiry.
- Support phase-appropriate material enrolment, including drafting specifications and leading the Material Enrolment Board.
- Present and manage Change Controls from initiation to closure; evaluate Supplier Change Notifications (SCNs) and ensure timely completion.
- Act as subject matter expert for raw materials and compendial testing, performing impact assessments, deviations, CAPAs, and related change actions.
- Conduct routine raw material testing (e.g., pH, conductivity, appearance, USP gas testing), inspection, and sampling.
- Collaborate cross-functionally to support new material onboarding, release, and project activities.
- Support preparation, participation, and follow-up for regulatory inspections, internal audits, and client audits.
We are Looking For:
- Bachelor’s degree or higher in Life Sciences.
- Minimum 7 years of experience in the pharmaceutical or biopharmaceutical industry, including at least 5 years in Quality Control, Quality Systems, or Quality Assurance.
- Proven experience managing Change Controls, Deviations, and CAPAs.
- Strong knowledge of current Good Manufacturing Practices (cGMP).
- Demonstrated ability to drive a quality-focused culture, build effective processes, and collaborate across multiple sites and stakeholders in a fast-paced environment.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.
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 30 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 programs that support your mental and physical health
- Career development opportunities to 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?
Quality Assurance Specialist II, Raw Materials in Durham employer: Oxford Biomedica
Oxford Biomedica is an exceptional employer that fosters a collaborative and innovative work culture, where employees are empowered to make meaningful contributions to GMP-compliant manufacturing. Located in the vibrant area of Cowley and Yarnton, we offer competitive benefits, professional development opportunities, and a commitment to employee growth, making it an ideal place for those seeking a rewarding career in quality assurance.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Assurance Specialist II, Raw Materials in Durham
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect 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 mission and values. Tailor your answers to show how you embody being Responsible, Responsive, Resilient, and Respectful—qualities they value!
✨Tip Number 3
Practice makes perfect! Do mock interviews with friends or use online resources to get comfortable with common questions. The more you practice, the more confident you'll feel when it’s your turn to shine.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re genuinely interested in joining the OXB team and making a difference.
We think you need these skills to ace Quality Assurance Specialist II, Raw Materials in Durham
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your experience in Quality Assurance and how it aligns with our mission at OXB. We want to see how your skills can help us change lives!
Showcase Relevant Experience:When detailing your work history, focus on your experience in managing Change Controls, Deviations, and CAPAs. We’re looking for candidates who can demonstrate their knowledge of cGMP and quality-focused culture.
Be Clear and Concise:Keep your application straightforward and to the point. Use bullet points where possible to make it easy for us to see your qualifications and achievements at a glance.
Apply Through Our Website:We encourage you to submit your application directly through our website. It’s the best way for us to receive your details and ensures you’re considered for this exciting opportunity!
How to prepare for a job interview at Oxford Biomedica
✨Know Your cGMP Inside Out
Make sure you brush up on your knowledge of current Good Manufacturing Practices (cGMP). Be ready to discuss how you've applied these principles in your previous roles, especially in Quality Control or Assurance. This will show that you understand the importance of compliance in the pharmaceutical industry.
✨Prepare for Technical Questions
Expect to be asked about risk assessments, Change Controls, and CAPAs. Prepare specific examples from your past experience where you successfully managed these processes. This will demonstrate your expertise and ability to handle the responsibilities of the role.
✨Showcase Your Collaborative Spirit
Since this role involves cross-functional collaboration, think of instances where you've worked with different teams. Highlight your communication skills and how you’ve contributed to a quality-focused culture. This will resonate well with their emphasis on teamwork and respect.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions! Inquire about their approach to new material onboarding or how they handle regulatory inspections. This shows your genuine interest in the role and helps you assess if the company aligns with your values.
