Quality Assurance Specialist II

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!

Position Opportunity:

The QA Specialist II is responsible for providing comprehensive quality oversight for clinical and commercial cell and gene therapy operations at the Matica Biotechnology College Station facility. This position integrates responsibilities across material management, batch disposition, QA floor support, and select document control tasks to ensure compliance with applicable regulatory requirements and Good Manufacturing Practices (GMPs). This individual will interface with internal teams, suppliers, and clients to ensure materials and products meet quality standards prior to use or release. The role includes technical leadership for continuous quality improvement, batch record review, material release, deviation/Laboratory Investigation/ CAPA oversight, Laboratory Data review and support for new product introductions (NPIs).

How you will make an impact:

Batch Disposition:

• Review executed batch records, deviations, change controls, environmental monitoring reports, and supporting quality documentation to support timely disposition of batches.
• Maintain batch release tracking systems and ensure all release deliverables are completed.
• Draft and revise SOPs related to batch release and disposition processes.
• Represent QA in internal and external meetings related to product release.
• Apply risk-based decision-making when assessing batch release and deviation impact.
  
  
  

Material Management:

• 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.
• Maintain accurate material status and release tracking to support operational efficiency.
  
  
  

QA on the Floor:

• Provide on-the-floor QA support for material receipt, gowning qualification, manufacturing and quality control area walkthroughs, and inspection readiness.
• Support deviation investigations and CAPA implementation as owner or approver.
• Ensure adherence to Good Documentation Practices (GDP) and support real-time record review.
• Provide support to the internal audit program, as required.
  
  
  

Document Control:

• Support the coordination of document updates related to disposition, materials, and manufacturing processes as needed.
• Ensure controlled records associated with batch disposition, material management, and QA processes are accurate and compliant.
• Assist with issuing and managing controlled documents as needed for production or QA activities.
  
  
  

Audit and Inspection Support:

• Support client and regulatory inspections by preparing and presenting QA records and participating in inspection activities.
• Assist with development of responses and implementation of corrective actions from audit findings.
  
  
  

Metrics & Continuous Improvement:

• Track and trend metrics related to material release.
• Participate in quality system improvement projects and audit preparedness initiatives.
• -Support data collection and reporting for Quality Management Review (QMR).
• Identify compliance gaps during internal audits and contribute to audit preparedness and follow-up actions.
  
  
  

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.

As a future Matican you bring:

Education

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

Experience

• 2–3 years of cGMP experience in Quality Assurance, with emphasis in batch disposition, Quality data review, materials management, or floor QA support.
  
  
  

Knowledge

• Strong understanding of cGMP regulations (21 CFR 210/211, EU GMPs, ICH guidelines), supply chain fundamentals, and quality systems.
  
  
  

Skills

• Strong written and verbal communication, including technical writing.
• Proficiency in Microsoft Office tools and Quality Management Systems.
• Proven ability to manage multiple priorities and meet timelines.
• Ability to work independently and as part of a cross-functional team.
• Gowning qualification required or must be obtained upon hire.
  
  
  

Competencies we look for:

Commitment to Excellence, Problem Solving/Decision Making/Analytical Thinking, Communication Skills, Teamwork/Cooperation/Supportiveness, Flexibility/Adaptability, Initiative/Taking Ownership, Focus on Safety, Ethical/Trustworthiness, Work Ethic/Reliability, Thoroughness, Customer Service

We Value:

Matica’s Values are at the forefront of everything we do, our culture, and the decisions we make.

• Start with Safety & Quality
• Choose the Path of Openness, Honesty, and Integrity
• Nurture Our Differences to Enable Our Collective Success
• Learn Continuously to Ensure Our Value and Relevance
• Commit to Delivering Life Altering Therapies