Biotech Raw Materials QA Specialist

Humacyte Global Inc; Durham (NC); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Stock Options

401k Plan with 4% Match

Medical, Vision and Dental Plans

Company Paid Disability

Company Paid Life Insurance

23 Days Paid Time Off

10 Holidays + 2 Floating Holidays

Paid Parental Leave

Job summary

Humacyte Inc. seeks a Supplier Quality Specialist to support raw material inspection, review, and release for GMP manufacturing. You will coordinate third‑party testing, maintain quality records, and assist with supplier investigations under leadership.

The role emphasizes regulatory compliance and material availability for production. Ideal candidates have 2–4 years in biotech/pharma QA, familiarity with GMP, USP, and supplier documentation, and strong attention to detail.

Qualifications

• High School or GED required; Bachelor’s Degree preferred.
• 2–4 years of experience in Quality within biotechnology, pharmaceutical, or medical device field.
• Minimum 2 years in Raw Material programs; regulatory inspections a plus.
• Must work holidays/weekends OT; gowning/PPE guidelines apply.
• Strong understanding of USP, EudraLex, PDA reports, FDA Guidance; cGMP experience.
• Ability to review quality records and coordinate with multiple departments.

Responsibilities

• Perform raw material and component release activities per procedures and specs.
• Review CoA/CoC, shipping/receipt records; maintain release docs.
• Coordinate third‑party testing and track status for material release timelines.
• Review lab reports, raise discrepancies or quality concerns.
• Perform incoming inspection activities for raw materials and components.
• Maintain raw material release records and quality system documentation.
• Assist with supplier investigations, nonconformances, deviations, and SCARs.
• Support supplier qualification and monitoring with required documentation.
• Generate and maintain raw material release metrics and reports.
• Participate in continuous improvement of material release processes and supplier quality programs.
• Support internal and supplier audits and regulatory inspections with documentation.
• Assist in SOP, form, specification, and work instruction revisions.
• Support inventory disposition decisions via timely release activities.

Skills

Quality systems

Regulatory compliance

Data review

Attention to detail

Effective communication

Prioritization

Cross-functional coordination

Troubleshooting

Education

Bachelor’s Degree preferred

High School or GED required

Tools

Microsoft Office

Electronic quality systems

Job description

Humacyte Inc. seeks a Supplier Quality Specialist to support raw material inspection, review, and release for GMP manufacturing. You will coordinate third‑party testing, maintain quality records, and assist with supplier investigations under leadership.

The role emphasizes regulatory compliance and material availability for production. Ideal candidates have 2–4 years in biotech/pharma QA, familiarity with GMP, USP, and supplier documentation, and strong attention to detail.