Document Control Specialist I, Quality Assurance

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 Document Control Specialist I is responsible for maintaining the document control process at Matica Biotechnology’s College Station, TX facility. This role ensures the accurate processing, implementation, and management of controlled documents in compliance with current Good Manufacturing Practices (cGMP) and company-wide procedures. The specialist will manage change requests within an electronic document management system (eDMS) and ensure timely and efficient distribution of controlled documents to manufacturing and other departments. This position requires strong attention to detail, organizational skills, and the ability to work independently on routine tasks with minimal supervision. Additionally, the role supports internal and external audits, contributes to process improvements, and collaborates with cross-functional teams to optimize document workflows.

How you will make an impact:

Primary Responsibilities

• Process GMP documents with a keen focus on proofreading, editing, and ensuring compliance with regulatory, industry, and internal guidelines.
• Maintain an organized system to track document status using Excel, eDMS, and Outlook.
• Ensure timely review, approval, and turnover of controlled documents.
• Scan, file, and archive controlled documents both electronically and physically to ensure proper document retention and easy retrieval.
• Prioritize and manage document processing tasks with varying turnaround times, ensuring timely review and revision of procedures, specifications, and forms.
• Collaborate with cross-functional teams, (e.g., Manufacturing and Quality Control), to address document control requests while adhering to established procedures.
• Support cGMP records management by organizing, retrieving, and maintaining controlled records in accordance with regulatory guidelines and company policies.
• Track, issue, and maintain compliance of documentation within regulatory requirements.
• Coordinate record retrieval requests and provide written responses for information inquiries.
• Maintain employee training files and ensure proper documentation.
• Assist in preparing documentation for regulatory and client audits, ensuring records are inspection-ready at all times. Ensure documentation is readily accessible for client and regulatory audits.
• Identify and support process improvements to enhance document control workflows and compliance.
• Develop and deliver basic presentations as needed.
• Perform other duties as assigned.

As a future Matican you bring:

Education

• Associate’s degree in a relevant field (e.g., Life Sciences, Business Administration, or a related technical field), or an equivalent combination of education and industry experience.
• High school diploma or GED may be considered with at least 2 years of relevant industry experience in document control or quality assurance within a cGMP environment.

Experience

• Up to 2 years of document control experience, with at least 1 year in a quality assurance role within a cGMP environment preferred.
• Experience with electronic document management systems (eDMS) such as Veeva, MasterControl, or similar preferred.

Knowledge

• Basic understanding of cGMP regulations, document management systems, and document creation.

Skills

• Strong writing, proofreading, and organizational skills.
• Proficiency in Microsoft Office Suite and document tracking systems.
• Ability to work on a computer for extended periods.
• Strong attention to detail and ability to support process improvements within document control.

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