Quality Assurance Specialist II, Raw Materials
About The Position
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.
Requirements
- 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.
Responsibilities
- 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.
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
- A company that lives its values: Responsible, Responsive, Resilient, Respect
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
