Senior Quality Assurance 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 primary responsibility of this role is to provide quality oversight and support for shop floor and batch disposition processes. Additionally, the individual will oversee and support the validation function. This role also involves approving investigations, CAPAs, Change Controls, and both internal and external inspections.

ESSENTIAL FUNCTIONS:

• Provide shop floor Quality oversight of cGMP departments, including labeling, inspection, and AQL processes, QA walkthroughs, and review of batch records and logbooks.
• Provide Quality oversight of the Validation department by collaborating on projects, reviewing and approving validation documents such as procedures, protocols, reports, user requirements specifications, deviations etc., ensuring that all user and compliance requirements are met.
• Populate Lot Release Protocols (LRPs) and perform QA Batch Disposition on clinical and commercial batches per company disposition procedures
• QA Approve quality records (Change Control, CAPA, Deviation); may own as necessary.
• Create, write, review and approve QA dept Standard Operating Procedures (SOPs), as needed.
• Represent Quality Assurance on project teams and in meetings and through interactions with the FDA and partners, and audits/inspections as needed.
• Ensure cGMP documents adhere to Humacyte policies, SOPs, and cGMP requirements.
• Other duties, as assigned.

EXPERIENCE & QUALIFICATIONS:

• Minimum 8 years of Quality experience in a GMP regulated pharmaceutical, biotechnical, or medical device industry, preferably on the shop floor.
• Understanding of batch release activities; prior batch disposition experience preferred
• Background in one or more specialties in biotechnology: pharmaceutical and/or biological development, biomedical engineering, regenerative medicine or chemical engineering
• Experience with paper and electronic Quality Management Systems.
• Experience investigating and/or approving product complaints preferred.
• Strong background in both written and oral communication with emphasis on effective technical writing
• Will be required to work evenings, off-hours, holidays, or extended periods of time on occasion.Excellent communication and interpersonal skills.
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook.
• Strong ability to work in a fast-paced team environment with fluctuating priorities and demonstrated ability to collaborate within cross functional teams.
• Excellent organizational and time management skills with ability to set own priorities in a timely manner.
• High degree of flexibility and adaptability.
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills.
• Represents the organization in a positive and highly professional manner.

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.