Quality Assurance Specialist I, Raw Materials

Join Us in Changing Lives

Location: on-site role Durham NC

AtOXB our people are at the heart of everything we do. Were on a mission to enable life-changing therapies to reach patients around the worldand were 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.

Were currently recruiting for aQuality AssuranceSpecialistRaw Materials to join our team. In this role you willbe providing qualityoversight ofactivities supportingtheend-to-endproductionprocessin accordance withOXBpolicies standardsproceduresand 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 materialinspection.

• Conduct raw material samplingandinspection.

• Createraw materialmanagementdocumentation.

• Oversee material shipmentsand temperature-controlled material movements.

• Completeimpact assessments for supplier and material changes.

• Supportarea and process walkthroughs withinManufacturingWarehouseQuality ControlandUtility areas.

• Ensure compliance with applicable procedures and production follow up on potential non-compliances and escalate tomanagementas 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 QualityControl and Compliance asrequired.

• Supportmanufacturing activities within the production suites to support potential quality/compliance events provide guidance on documentationcommentsand ensure compliance with applicable procedures.

• Build andmaintaincross-functionalrelationships to effectivelyaccomplishresponsibilities make improvements and resolve issues.

We are Looking For:

• Associates degree or higher inlifesciences discipline.3 yearsin a GMP regulated environment may be substituted in lieu of degree.

• 2 yearsin a GMP regulated environment in any function.

• Experiencecompletingraw materialsampling 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 worlds most innovative pharmaceutical and biotechnology companies providing viral vector development and manufacturing expertise in lentivirus adeno-associated virus (AAV) and adenoviral vectors. OXBs 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 programsthat support your mental and physical health
• Career development opportunitiesto 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 were future-focused and growing fast. We succeed togetherthrough passion commitment and teamwork.

Ready to Make a Difference