Senior Specialist, Quality Assurance
oxfordbiom•Durham, NC
•Onsite
About The Position
OXB is seeking a Quality Assurance Senior Specialist to join their Quality Assurance team at their new commercial-scale viral vector facility in Durham, North Carolina. This role is responsible for the quality oversight of raw material management, including coordinating shipping and testing with contract testing labs, sampling, inspection, and release. The position plays a key part in advancing the company's mission to enable life-changing therapies to reach patients worldwide.
Requirements
- Bachelor’s degree or higher in Life Sciences.
- Minimum 5 years of experience in the pharmaceutical or biopharmaceutical industry, including Quality Control, Quality Systems, or Quality Assurance, with at least 3+ years in Quality Control.
- 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.
- External applicants must be eligible to work in the United States.
Responsibilities
- Act as subject matter expert for raw material enrollment process at OXB Durham.
- Conduct raw material sampling and inspection.
- Collaborate with Manufacturing, MS&T and QA to complete phase appropriate Raw Material Risk Assessments.
- Collaborate with material suppliers to ensure proper supporting documentation is provided to OXB Durham.
- Quality oversight of method lifecycle and method implementation strategies.
- Quality oversight of day-to-day QC operations.
- Support regulatory inspections, internal audits, and client audits.
- Build and maintain cross-functional relationships with OXB colleagues and clients to collaborate, improve processes, and solve problems efficiently.
- Independently escalate compliance concerns when observed.
- QA support and ownership of QMS records including investigations, change controls, CAPAs, etc.
- Navigate compendia (USP and EP) to support material testing requirements and RM spec creation.
- Final disposition of raw materials.
- Support Supplier Change Notifications and facilitate impact assessment completion, with cross-functional teams, in QMS.
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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
