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- Tasks: Ensure quality oversight of raw materials and support production processes.
- Company: Join OXB, a leader in life-changing therapies and viral vector development.
- Benefits: Enjoy wellbeing programs, career growth opportunities, and a collaborative culture.
- Why this job: Make a real impact in advancing innovative therapies for patients worldwide.
- Qualifications: Life sciences degree or GMP experience; strong knowledge of cGMP required.
- Other info: Work in state-of-the-art facilities with a supportive team.
The predicted salary is between 36000 - 60000 ÂŁ per year.
At OXB our people are at the heart of everything we do. We are on a mission to enable life‑changing therapies to reach patients around the world and we are 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 new opportunities to join us. We are currently recruiting for a Quality Assurance Specialist – Raw Materials to join our team. In this role you will provide 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:
- Act as subject matter expert for raw material inspection.
- Oversee material shipments and temperature‑controlled material movements.
- Complete impact assessments for supplier and material changes.
- Support area and process walkthroughs within Manufacturing, Warehouse, Quality Control and Utility areas.
- Ensure compliance with applicable procedures and production; follow up on potential non‑compliances and escalate to management as necessary.
- Support preparation, participation and follow‑up for regulatory inspections, internal audits and client audits.
- Support all areas of Quality Assurance including Document Control, Training, QA for Quality Control and Compliance as required.
- Support manufacturing activities within the production suites to address potential quality/compliance events, provide guidance on documentation comments and ensure compliance with applicable procedures.
- Build and maintain cross‑functional relationships to effectively accomplish responsibilities, make improvements and resolve issues.
We are looking for:
- Associate’s degree or higher in a life‑sciences discipline.
- Three years in a GMP‑regulated environment may be substituted in lieu of a degree.
- Two years in a GMP‑regulated environment in any function.
- Experience completing raw material sampling and inspection.
- Strong knowledge of current Good Manufacturing Practices (cGMP).
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, supported by robust quality‑assurance systems, analytical methods and depth of regulatory expertise.
Why join us:
- 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 are future‑focused and growing fast. We succeed together through passion, commitment and teamwork. Ready to make a difference?
Location: On‑site role, Durham, NC
Employment Type: Full Time
Vacancy: 1
Quality Assurance Specialist II, Raw Materials in North East employer: Oxford Biomedica
Contact Detail:
Oxford Biomedica Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Specialist II, Raw Materials in North East
✨Tip Number 1
Network like a pro! Reach out to current employees at OXB on LinkedIn or through mutual connections. Ask them about their experiences and any tips they might have for landing the Quality Assurance Specialist role.
✨Tip Number 2
Prepare for the interview by brushing up on your cGMP knowledge and raw material inspection processes. We want you to showcase your expertise and how it aligns with OXB's mission of delivering life-changing therapies.
✨Tip Number 3
Practice common interview questions related to quality assurance and compliance. Think about specific examples from your past experience that demonstrate your skills and how you've handled challenges in a GMP-regulated environment.
✨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 your genuine interest in joining the OXB team and contributing to our mission.
We think you need these skills to ace Quality Assurance Specialist II, Raw Materials in North East
Some tips for your application 🫡
Show Your Passion: When writing your application, let your enthusiasm for the role shine through. We want to see how your values align with ours—Responsible, Responsive, Resilient, and Respectful. Share why you’re excited about contributing to life-changing therapies!
Tailor Your CV: Make sure your CV is tailored to highlight your experience in a GMP-regulated environment. We’re looking for specific examples of your work with raw materials and quality assurance, so don’t hold back on those details!
Be Clear and Concise: Keep your application clear and to the point. We appreciate well-structured information that’s easy to read. Use bullet points where necessary to make your skills and experiences stand out!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re serious about joining our team!
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 these practices apply to raw material inspection and quality assurance. This will show that you’re not just familiar with the terms, but that you understand their importance in ensuring compliance and quality.
✨Showcase Your Experience
Prepare specific examples from your past roles where you’ve successfully handled raw material sampling and inspections. Highlight any challenges you faced and how you overcame them. This will demonstrate your hands-on experience and problem-solving skills, which are crucial for this role.
✨Emphasise Teamwork and Collaboration
Since building cross-functional relationships is key in this position, think of instances where you’ve worked effectively with other teams. Be ready to share how you’ve contributed to a collaborative environment and resolved issues together. This will align with OXB’s values of being respectful and responsive.
✨Prepare for Regulatory Questions
Expect questions about your experience with regulatory inspections and audits. Familiarise yourself with common audit processes and be prepared to discuss how you’ve supported these activities in the past. Showing that you can navigate these situations will highlight your readiness for the role.
