Quality Assurance Specialist II, Raw Materials

About the role

Join Us in Changing Lives
Location: on-site role, Durham, NC
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.

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.

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.

Qualifications

• Experience with cGMP regulations and compliance.
• Knowledge of raw materials and compendial testing.
• Ability to manage and prioritize tasks effectively.
• Strong communication and interpersonal skills.
• Proficiency in Microsoft Office Suite.

Skills

• Strong problem-solving and critical thinking skills.
• Excellent organizational and time management skills.
• Ability to work independently and as part of a team.
• Fluency in English.

Benefits

• Competitive total reward packages.
• Wellbeing programs that support your mental and physical health.
• Career development opportunities to help you grow and thrive.
• A supportive, inclusive, and collaborative culture.
• State-of-the-art labs and manufacturing facilities.
• A company that lives its values: Responsible, Responsive, Resilient, Respect.

Pay

• Competitive salary based on experience and qualifications.

Schedule

• Full-time position.