Senior Specialist, QA Operations
Quality Assurance | Research Triangle Park, NC | Full Time
Humacyte's mission is to become the leading company in novel, off-the-shelf extracellular matrix tissue products, and especially those that could provide lifesaving improvements in treatments for vascular conditions.
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.
- Provide Quality Assurance “on the floor” support for real-time review of facility, utility, and production records required for biologics product manufacturing
- Provide collaborative Quality support for Bioprocessing in the completion of biologics production and compile data to provide documentation for Quality System metrics
- Responsible for the review of batch records in support of clinical and/or commercial manufacturing.
- Maintain approved labeling materials (label master and revisions).
- Maintain batch related documentation including but not limited to issuance and management of batch records, logbooks, and laboratory notebooks.
- Interface with Quality Assurance, Engineering, Validation, Facilities, Maintenance, Quality Control and/or other colleagues to ensure systems, processes, facilities, utilities, equipment, and instruments are in accordance with current Good Manufacturing Practices and Humacyte standards.
- Provide ongoing oversight and training for bioprocessing staff to assure consistent and compliant manufacturing operations with compliant supporting documentation
- Assist with organizational communication between Quality, bioprocessing, and enterprise operational staff to facilitate timely and compliant review of all records required for domestic and international distribution of biologic products
- Coordinate with bioprocessing, Quality, and technical Subject Matter Experts (SME) in the remediation and proper documentation of process-related deviations
- Participate in the execution of process risk assessments that support process lifecycle evaluation reports
- Ensure compliance with cGMP, regulatory, and industry standards
- Bachelor’s degree or equivalent level of industry-specific experience
- Minimum 5 years prior experience in hands-on manufacturing of biologic products in a regulated environment
- Prior experience in technical evaluation and support of biologic product manufacturing required, with solid understanding of fundamentals in cell biology, biochemistry, process development, and process validation
- Experience with bioprocessing of Human Cell and Tissue-Based biologic products in a cGMP/cGTP environment preferred
- In-depth functional understanding of applied current Good Manufacturing Practices, Process Validation Lifecycle, and other regulated aspects of biopharmaceutical manufacturing of Clinical Trial Materials and licensed biologic products
- Technical and functional understanding of commonly used biomanufacturing process equipment, systems, and supporting enterprise processes
- Pragmatic and collaborative understanding of subject matter expertise, training programs, operator qualification, cleanroom qualification and maintenance, and role of Quality on-the-floor support in compliant biopharmaceutical manufacturing
- Specific, demonstrated expertise in review of batch production record documentation along with supporting maintenance, cleaning, and Quality System documentation (CAPA, Change Control, Deviation, NonConforming Materials) as specified in U.S. and international biologics regulations and guidance
- Prior experience with late-stage biologic product approvals and pre-approval regulatory inspections
- Stock Options
- 401k Plan with Matching
- Medical, Vision and Dental Plans
- Long Term/Short Term Disability
- Life Insurance
- 3 Weeks’ Vacation
- 5 Personal Floating Days
- 8 Sick Days
- 6 Company Holidays
- Career Development and Training