Quality Specialist III – Humacyte, Inc. – Research Triangle Park, NC

**Please note, Humacyte does not provide sponsorship at this time.**

Humacyte, Inc., a biotechnology pioneer, discovers, develops and delivers innovative, award winning human biotherapies. We are currently developing multiple vascular tissue engineered therapies and expanding our business model. With a broad pipeline of potential new therapy applications, we continue to build our organization and scientific teams. We are looking for additional biomedical research and development colleagues to continue to build our expanding team.

Candidates will be expected to work both independently and collaboratively as part of the Humacyte organization. Applicants must be highly self-motivated, with solid communication skills, and demonstrates the ability to work in a team environment and lead other professionals and peers.

Position Background:

The Quality Specialist III provides support to the overall Quality Assurance program at the site. Ensures manufacturing operations are within cGMP and GTP regulations and local procedures.

Position reports to Director, Quality Assurance

Primary Responsibilities:

• Provide oversight to operations on the shop floor, supporting operators and support staff as needed to identify and address product quality and compliance issues as they arise
• Ensures shop floor processes are aligned and compliant to existing procedures
• Review and approve production batch records to ensure adherence to Humacyte policies, SOPs, and cGMP requirements
• Interface with the QA Batch Release team to assist with batch record release and compliance issues
• Initiate deviation reports and partner with the QA Batch Release team for issue resolution
• Works cross-functionally to resolve outstanding issues from the manufacture or testing of the batch (e.g., batch record review, investigations, testing, Change controls, etc.) to ensure the timely submission/release of the material
• Responsible for incoming material release in support of manufacturing operations in collaboration with manufacturing and supply chain
• Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Humacyte quality practices
• Write, review and approve Standard Operating Procedures (SOPs), as needed.
• Interact with FDA, partner and supplier auditors/inspectors as needed
• Represent Quality Assurance on project teams and in meetings
• Cross trains to support other functional quality areas, including but not limited to deviation management, environmental monitoring investigations, and inspection support
• Assists with training of new team members
• Other duties, as assigned

General Competencies:

• Possess a positive attitude and optimistic outlook
• Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
• Excellent organizational and time management skills with ability to set own priorities in a timely manner
• High degree of flexibility and adaptability
• Strong communication (verbal and written) and organizational skills
• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
• Strong interpersonal, business and communication skills
• Ability to work effectively within a team to set goals, resolve compliance issues in scientific and industry-standard terms, as required.
• Routinely communicate findings and information to peers and other team members; transparency and knowledge sharing is expected and practiced
• Will spend a portion of time in clean room environment to provide oversight to manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines

Special Competencies:

• Strong problem solving and analytical skills
• Familiarity with clean room operations and aseptic processing
• Familiarity with batch release activities is a strongly preferred skill necessary for success in this position; prior batch disposition experience is a plus
• Detailed oriented, self-motivated and scientifically driven
• Demonstrated ability to work in a cross functional team
• Excellent communication and interpersonal skills
• Firm understanding of Quality Management Systems processes and the ability to lead investigations
• Proactively investigate and resolve discrepancies
• Ability to resolve processing challenges within manufacturing
• Familiarity with inspection methods and techniques is an asset
• May be required to work, evenings, off-hours, and extended periods of time

QUALIFICATIONS:

• Bachelor’s degree; science degree preferred
• Minimum 7-8 years of pharmaceutical work experience, preferably in Biologics manufacturing
• Demonstrated background in support of cGMP Quality management systems
• Experience in evaluating technical quality problems and providing recommendations for corrective actions
• Background in one or more specialties of Chemical Engineering, Biomedical Engineering, Biology or Chemistry
• ASQ certification a plus
• Strong understanding of cGMP, ISO and ICH guidance’s in the biotech manufacturing environment

Perks:

• Stock Options
• 401k Plan with Matching
• Medical, Vision and Dental Plans
• Long Term/Short Term Disability
• Life Insurance
• 23 Days Paid Time Off (PTO)
• 11 Paid Holidays
• Paid Parental Leave Policies