Biotech Materials Quality Specialist

Regulatory Jobs; Durham (NC); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Stock Options

401k Plan with 4% Match and no Vesting

Medical, Vision and Dental Plans

Company Paid Disability

Company Paid Life Insurance

PTO 23 Days

Holidays + Floating Holidays

Parental Leave Policies

Job summary

Humacyte Inc in Durham, NC, seeks a Supplier Quality Specialist to support the supplier quality function, focusing on raw material inspection, review, and release to ensure GMP manufacturing continuity.

The role collaborates with Quality leadership to process CoA/CoC reviews, coordinate testing, and maintain quality records while supporting regulatory inspections and continuous improvement initiatives.

Qualifications

• 2–4 years of experience in Quality within biotech, pharmaceutical, or medical device fields.
• Minimum 2 years of experience in Raw Material programs.
• Experience supporting regulatory inspections is a plus.

Responsibilities

• Perform raw material and component release activities per procedures and specs.
• Review Certificates of Analysis (CoA), Certificates of Conformance (CoC), shipping records.
• Coordinate samples submission to third-party testing labs and track status.
• Review third-party lab reports against specs and escalate discrepancies.
• Maintain raw material release records and related quality documentation.
• Assist with supplier investigations, deviations, and SCARs.
• Support supplier qualification and monitoring with documentation.
• Generate raw material release metrics and reporting tools.
• Contribute to continuous improvement of material release processes.

Skills

Raw material release

Quality systems

Documentation review

Regulatory compliance

Communication

Education

Bachelor’s degree (preferred)

High School or GED required

Tools

Microsoft Office

Electronic quality systems

Job description

Humacyte Inc in Durham, NC, seeks a Supplier Quality Specialist to support the supplier quality function, focusing on raw material inspection, review, and release to ensure GMP manufacturing continuity.

The role collaborates with Quality leadership to process CoA/CoC reviews, coordinate testing, and maintain quality records while supporting regulatory inspections and continuous improvement initiatives.