Quality Assurance Specialist II, Raw Materials

Quality Assurance Specialist II, Raw Materials

Location:

Durham, NC, US

Company: oxfordbiom

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
.

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:

• Act as subject matter expert for raw material inspection.
• Conduct raw material sampling and inspection.
• Create raw material management documentation.
• 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 requirements. Perform follow up on potential non‑compliances and escalated 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 support 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. 3+ years in a GMP regulated environment may be substituted in lieu of degree.
• 2+ 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.

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 commercialization. These capabilities are supported by robust quality‑assurance systems, analytical methods, and depth of regulatory expertise.

• 🧘 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.