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 Material programs, required
• Prior experience supporting regulatory inspections a plus
• Position may require working holidays, weekends, and over-time
• May be required to regularly to sit; stand for prolonged periods of time
• May spend time in a manufacturing operations environment and will be required to meet applicable gowning and personal protective equipment guidelines, as applicable
• Strong understanding of regulations and compendial guidance for Raw Material program applications, including USP, EudraLex, PDA technical reports, FDA Guidance for Industry
• Working knowledge of cGMP regulations and quality system requirements.
• Understanding of raw material release processes and controlled documentation practices.
• Ability to review quality records for accuracy, completeness, and compliance.
• Familiarity with supplier documentation including Certificates of Analysis, specifications, and testing requirements.
• Ability to coordinate activities with Manufacturing, Warehouse, QC, Supply Chain, and external testing laboratories.
• Strong attention to detail and data review skills.
• Basic knowledge of deviations, CAPAs, change controls, and quality investigations.
• Effective verbal and written communication skills.
• Ability to prioritize multiple activities and meet established timelines.
• Proficiency with Microsoft Office applications and electronic quality systems.

COMPENSATION & BENEFITS HIGHLIGHTS:

• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term Disability
• Company Paid Life Insurance
• 23 Days Paid Time Off (PTO)
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies

** Please note, Humacyte does not provide U.S. employment sponsorship and does not accept unsolicited resumes from 3rd party firms and/or agency recruiters. **

The statements in this position profile are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time. Humacyte is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, Humacyte is committed to achieving its business objectives in compliance with all federal, state and local law.