OXB · 13 hours ago
Quality Assurance Specialist II, Raw Materials
Durham, NC
Full-time
Onsite
Entry, Mid Level
2+ years expOXB 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. The Quality Assurance Specialist, Raw Materials will provide quality oversight of activities supporting the end-to-end production process in accordance with OXB policies, standards, procedures and cGMP.
BiotechnologyGeneticsTherapeutics
No H1B
Responsibilities
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 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 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
Qualification
Required
Associate's degree or higher in 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)
Benefits
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
Company
OXB
OXB (LSE: OXB) is a global quality and innovation-led contract development and manufacturing organisation (CDMO) in cell and gene therapy with a mission to enable its clients to deliver life changing therapies to patients around the world.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$217.05MKey Investors
Oaktree Capital ManagementSerum Institute of India Pvt. Ltd.
2025-08-01Post Ipo Debt· $60M
2021-09-22Post Ipo Equity· $68.08M
2019-05-01Post Ipo Equity· $69.83M
Leadership Team
Emily Yu
Oxford BioMedica CMO
Recent News
2026-01-16
2026-01-16
2026-01-16
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