Job at a glance
The Quality Assurance Specialist provides comprehensive quality oversight for clinical and commercial cell and gene therapy operations in College Station, TX. Reporting to the QA Ops Manager, this role integrates responsibilities across material management, batch disposition, QA floor support, and document control. The position ensures compliance with Good Manufacturing Practices (GMPs) and applicable regulatory guidelines by collaborating with internal teams, suppliers, and clients to verify materials and products meet quality standards.
Responsibilities: Batch Disposition: Review executed batch records, deviations, change controls, environmental monitoring reports, and quality documentation adhering to ALCOA+ data integrity principles to support product disposition. Draft and revise disposition-related SOPs, manage tracking systems, and escalate compliance risks. Material Management: Acquire, review, and approve cGMP documentation (such as CoAs, test results, and BSE/TSE statements).
Label, track, and release or reject raw materials while updating specifications, part numbers, and material statuses. QA on the Floor: Perform quality oversight in manufacturing, warehouse, and quality control (QC) environments. Conduct walkthroughs, support gowning qualification, facilitate real-time Good Documentation Practices (GDP) compliance, and assist with deviation investigations and CAPAs.
Document Control & Audit Support: Coordinate document updates, issue controlled production records, and support internal and external audits by gathering, preparing, and presenting QA files. Leadership & Metrics: Trend material release metrics, support Quality Management Reviews (QMR), drive continuous improvement initiatives, and mentor junior QA staff. Working hours: 8:00 AM - 5:00 PM Skills: Technical writing capabilities for reviewing and revising SOPs and regulatory responses.
Applied experience using risk-based decision-making during deviation assessments and batch releases. Mentorship and onboarding experience to guide junior QA personnel. Exposure to cleanroom environments, material handling, and inspection readiness initiatives. Education: Bachelors Experience: 1-4 years Qualifications: Education: Bachelor???s degree in a life science or related field (or an equivalent combination of education and industry experience).
Experience: Minimum of 1-5 years of cGMP experience in Quality Assurance with an emphasis on batch disposition, material management, floor support, or QC data review. Industry Experience: Specific background supporting Cell and Gene Therapy operations. Regulatory Knowledge: Solid understanding of cGMP regulations (21 CFR 210/211, EU GMPs, ICH guidelines), quality systems, and supply chain fundamentals.
Technical Skills: Proficiency with Quality Management Systems (QMS) and Microsoft Office suite. Operational Capabilities: Ability to make sound compliance decisions with minimal supervision, handle multiple priorities to meet deadlines, and work effectively in cross-functional team settings. Apply today! Spherion has helped thousands of people just like you find work happiness! Our experienced staff will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company.
Whether you're looking for temporary, temp-to-perm or direct hire opportunities, no one works harder for you than Spherion. Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Spherion, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants.
If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected]. Pay offered to a successful candidate will be based on several factors includ