What are the responsibilities and job description for the Quality Assurance Specialist II position at HUMACYTE GLOBAL INC?
Job Description
Job Description
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 Quality Assurance Specialist II is responsible for supporting Humacyte’s Quality Management Systems, specifically in the management of regulated documents and training. This role involves creating, revising, and maintaining documents, as well as assigning training within the Quality Management System, ensuring compliance with regulatory requirements and internal standards. The ideal candidate is detail-oriented and possesses strong communication and organizational skills.
ESSENTIAL FUNCTIONS :
- Assist in the creation, revision, approval, periodic review, and control of documents within the QMS, adhering to approved timelines.
- Track and monitor the status of documents throughout their lifecycle to ensure timely completion.
- Issue and reconcile controlled documents, including laboratory notebooks, logbooks, and labels.
- Train and provide support to staff on the use of the QMS.
- Support the site archive process and offsite document storage.
- Create and assign training for all staff.
- Participate in the development, maintenance, and reporting of Quality Systems metrics.
- Support audits by ensuring document compliance with regulatory standards and assisting in the preparation of documentation for inspections.
- Continuously improve document control processes and recommend enhancements.
- Serve as a subject matter expert (SME) for designated tasks related to the Quality Management System (QMS) and existing eQMS (MasterControl).
- Perform other duties as assigned.
EXPERIENCE & QUALIFICATIONS :
COMPENSATION & BENEFITS HIGHLIGHTS :
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.
