Matica Biotechnology, Inc. · 1 month ago
Quality Assurance Specialist IV - QA Systems
College Station, TX
Full-time
Hybrid
Senior Level
5+ years expMatica Biotechnology is at the forefront of biopharmaceutical research and development, specializing in cell and gene therapy. The QA Specialist IV is responsible for ensuring compliance with quality systems and regulatory standards through internal audits, supplier qualification, and material specification management.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
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
Qualification
Required
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 qualification program, internal audit, and materials management
Strong understanding of cGMP regulations (21 CFR 210/211, EU GMPs, ICH guidelines), supply chain fundamentals, and quality systems
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
Company
Matica Biotechnology, Inc.
Matica Biotechnology, Inc.
51-200 employees
H1B Sponsorship
Matica Biotechnology, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2023 (4)
2022 (1)
2021 (1)
Funding
Current Stage
Growth StageLeadership Team
Paul Kim
Chief Executive Officer
Recent News
Precedence Research
2025-11-27
2025-11-04
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