Quality Assurance Specialist IV - QA Systems

Quality Assurance Specialist IV - QA Systems

Join to apply for the Quality Assurance Specialist IV - QA Systems role at Matica Biotechnology, Inc.

Matica Biotechnology is at the forefront of biopharmaceutical research and development. The Matica Bio team brings an average of 15 years of cell and viral vector manufacturing experience to the development and manufacture of advanced therapy products. At our purpose-built GMP facility in College Station, Texas, we provide rapid development and scale-up of cell and gene therapies, vaccines, and Oncolytics meeting worldwide regulatory compliance.

The true value of a CDMO is determined by the quality of its people. Matica Bio consists of a dedicated team of experts. We’re a cell and gene therapy CDMO powered by people, and our people provide real benefits to the quality, safety and speed of the cell and gene therapy development pathway. Our inventive thinking and foresight help us strategize the best path to take therapies from the lab to the market.

Come join our dedicated team and Make it Happen With Matica Bio!

The QA Specialist IV is responsible for providing comprehensive quality systems oversight for clinical and commercial cell and gene therapy operations at the Matica Biotechnology College Station facility. This position integrates responsibilities across supplier and vendor qualification program, material specifications program and internal audit program to ensure compliance with applicable regulatory requirements and Good Manufacturing Practices (GMPs). This role ensures compliance with regulatory standards, internal policies by conducting audits, evaluating supplier performance, and driving continuous improvement initiatives.

This individual may provide support material release, deviation/ CAPA oversight, and document control as needed.

• Plan, execute, and document internal audits to ensure compliance with quality standards (GMP, 21 CFR).
• Identify nonconformities, issue audit reports, and track corrective and preventive actions (CAPAs).
• Collaborate with cross-functional teams to implement process improvements.
• Support hosting of client, partner, and regulatory agency audits/inspections, including preparation, execution, response, and follow-up activities.
• Ensure timely closure of audit findings and CAPAs from external inspections.

• Develop and maintain supplier qualification program and documentation.
• Perform risk-based supplier evaluations and periodic requalification based on performance and material impact.
• Communicate and support investigations related to supplier issues (e.g., supplier complaints, SCARs).
• Apply risk management principles (ICH Q9) to supplier qualification, material changes, and QMS findings.
• Conduct supplier/vendor audits and assessments to ensure adherence to quality and regulatory requirements.
• Monitor supplier/vendor performance and maintain approved supplier and approved material lists.

• Review, approve, and maintain material specifications for raw materials, components, and finished goods.
• Ensure specifications meet regulatory, quality, and functional requirements.
• Coordinate with Analytical Development, Procurement, Product Development, Manufacturing departments within Matica, to align specifications with operational needs.
• Support change control processes related to material specifications and ensured proper documentation.
• Communicate and support investigation process for suppliers/vendors (supplier complaints, SCARs).

• Acquire, review, and approve material-related cGMP documentation (e.g., CoAs, test results, BSE/TSE statements).
• Label, release, and track the status of quarantined, released, and rejected materials.
• Review and support generation of item numbers, material specifications, and part numbers.
• Interact with suppliers and clients for quality documentation and release clarification.

• Provide QA oversight for controlled documents related to supplier, material, and audit programs.
• Ensure documentation accuracy and version control within the electronic QMS (e.g., Veeva).

• Track and trend metrics related to Supplier/Vendor Qualification performance, Material Management and Internal Audit.
• Identify compliance gaps during internal audits and contribute to audit preparedness and follow-up actions.
• Support Quality Management Review (QMR) reporting and drive continuous improvement initiatives to enhance system effectiveness and compliance.

This role is dynamic and may evolve based on operational needs. The individual must be adaptable, detail-oriented, and committed to quality excellence in a regulated manufacturing environment.

• Bachelor’s degree in a life science or related field or an equivalent combination of education and industry experience.

• 5+ years of cGMP experience in Quality System experience, with emphasis supplier…