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
- 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).
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.
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
Education Level
Associate degree
