Supplier Quality Specialist

DEPARTMENT: Quality LOCATION: Durham, NC; Onsite/Not Remote COMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial opportunity, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), is currently approved for use in vascular trauma repair and is in late-stage clinical trials targeting multiple other applications including AV access for hemodialysis and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma also received the RMAT designation. For more information, visit www.Humacyte.com . JOB SUMMARY: The Supplier Quality Specialist, is responsible for supporting the Supplier Quality function through execution of raw material inspection, review, and release activities to ensure timely availability of materials for GMP manufacturing operations. This role performs routine supplier quality activities, supports incoming material disposition, coordinates third-party testing activities, maintains associated quality records, and assists with supplier quality investigations under the guidance of Supplier Quality leadership. This position contributes to maintaining compliance with applicable GMP requirements while supporting continuity of material supply for manufacturing operations. ESSENTIAL FUNCTIONS: With the support of the Senior Suppler Quality Lead and Senior Director of Quality: Perform raw material and component release activities in accordance with approved procedures and specifications. Review incoming material documentation, including Certificates of Analysis (CoA), Certificates of Conformance (CoC), shipping records, and receipt documentation. Coordinate submission of samples to qualified third-party testing laboratories and track testing status to support material release timelines. Review third-party laboratory test reports against approved specifications and escalate discrepancies, atypical results, or quality concerns. Execute incoming inspection activities for raw materials and components as required. Maintain raw material release records, inspection documentation, and associated quality system documentation. Assist with supplier investigations, nonconformances, deviations, complaints, and supplier corrective actions (SCARs). Support supplier qualification and monitoring activities through collection and maintenance of supplier quality documentation. Generate and maintain raw material release metrics and reporting tools. Participate in continuous improvement initiatives related to material release processes and supplier quality programs. Support internal audits, supplier audits, and regulatory inspections by providing documentation and subject matter support, as assigned. Assist in the review and revision of SOPs, forms, specifications, and work instructions associated with raw material programs. Support inventory disposition decisions through accurate and timely execution of release activities. Perform other Quality Assurance responsibilities as assigned. EXPERIENCE & QUALIFICATIONS: High School or GED required, Bachelor’s Degree, preferred 2-4 years of experience in Quality within the biotechnology, pharmaceutical, or medical device field, required Minimum 2 years of experience in Raw…

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