Matica Biotechnology, Inc. · 2 months ago
Quality Assurance Specialist II
College Station, TX
Full-time
Onsite
Entry, Mid Level
2+ years expMatica Biotechnology, Inc. is at the forefront of biopharmaceutical research and development, focusing on cell and gene therapy. The QA Specialist II is responsible for providing comprehensive quality oversight for clinical and commercial operations, ensuring compliance with regulatory requirements and Good Manufacturing Practices.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
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
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
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
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
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
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
Qualification
Required
Bachelor's degree in a life science or related field or an equivalent combination of education and industry experience
2–3 years of cGMP experience in Quality Assurance, with emphasis in batch disposition, Quality data review, materials management, or floor QA support
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
Gowning qualification required or must be obtained upon hire
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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