Quality Assurance Specialist II, Raw Materials
NCBiotech, Durham, NC, United States
Location: Durham, NC, US
Company: OXB
Position: Quality Assurance Specialist, Raw Materials
In this role, you will provide quality oversight of activities supporting the end-to-end production process in accordance with OXB policies, standards, procedures and cGMP. You will play a key part in advancing our mission and making a real difference.
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.
Qualifications
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.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.
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Company: OXB
Position: Quality Assurance Specialist, Raw Materials
In this role, you will provide quality oversight of activities supporting the end-to-end production process in accordance with OXB policies, standards, procedures and cGMP. You will play a key part in advancing our mission and making a real difference.
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.
Qualifications
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.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.
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