Biotech Supplier Quality Specialist (GMP Materials)

Humacyte; Durham (NC); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Stock Options

401k Plan with 4% Match

Medical, Vision and Dental Plans

Disability Insurance

Life Insurance

PTO 23 Days

Holidays & Parental Leave

Job summary

Humacyte Inc. is seeking a Supplier Quality Specialist to execute raw material inspection, review CoA/CoC, coordinate third-party testing, and support GMP manufacturing operations.

This role maintains release records, assists with supplier investigations, and supports supplier qualification and monitoring initiatives to ensure continuity of material supply. You will contribute to continuous improvement initiatives, oversee documentation, and collaborate with Manufacturing, QC, and Supply Chain

Qualifications

• 2–4 years experience in Quality within biotech, pharmaceutical, or medical device fields.
• Minimum 2 years in Raw Material programs and related regulatory knowledge.
• Familiarity with USP, EudraLex, PDA technical reports and FDA guidance.

Responsibilities

• Perform raw material release activities per approved procedures and specs.
• Review CoA/CoC, shipping records, and receipt documentation.
• Coordinate third-party testing submissions and track results.
• Review lab test reports and escalate discrepancies or quality concerns.
• Maintain raw material release records and quality system documentation.
• Assist with supplier investigations, nonconformances, and SCARs.
• Support supplier qualification, monitoring, and documentation collection.
• Generate raw material release metrics and reporting tools.
• Participate in continuous improvement of material release processes.
• Support internal and supplier audits and regulatory inspections.

Skills

Quality Assurance

Raw Materials

Documentation

Regulatory Compliance

Audits

CAPA

Cross-functional Collaboration

Education

Bachelor's degree

Tools

Microsoft Office

Electronic quality systems

Job description

Humacyte Inc. is seeking a Supplier Quality Specialist to execute raw material inspection, review CoA/CoC, coordinate third-party testing, and support GMP manufacturing operations.

This role maintains release records, assists with supplier investigations, and supports supplier qualification and monitoring initiatives to ensure continuity of material supply. You will contribute to continuous improvement initiatives, oversee documentation, and collaborate with Manufacturing, QC, and Supply Chain