job summary: We are seeking a Senior QA Specialist for a hands-on role at our manufacturing facility. This is a hands-on role for a problem-solver who thrives on the manufacturing floor. You will partner directly with Manufacturing and Engineering teams to ensure our gene therapies are produced to the highest standards of safety and efficacy, focusing on real-time quality support, batch record review, and deviation management. location: Morrisville, North Carolina job type: Temporary salary: $50 - 65 per hour work hours: 9 to 5 education: Bachelors responsibilities: Direct Manufacturing Oversight: Provide real-time QA support within the manufacturing environment. Perform line clearances, verify stage-gate transitions, and conduct routine facility walk-throughs to ensure the highest standards of Quality, safety, and efficacy are maintained under strict cGMP compliance.Deviation & Investigation Support: Facilitate the documentation and investigation of manufacturing deviations. Utilize Root Cause Analysis (RCA) tools (e.g., 5-Whys, Fishbone) to identify root causes and coordinate the implementation of CAPAs to prevent recurrence.Technical Batch Record Review: Execute comprehensive, timely reviews of executed batch records, QC data, and logbooks. Ensure all documentation is accurate and "Right First Time" (RFT) to support efficient lot disposition.Aseptic & Sterile Process Monitoring: Observe aseptic interventions and sterile processing activities to verify adherence to established procedures and regulatory requirements.SOP Maintenance & Optimization: Identify procedural gaps during manufacturing runs and partner with production teams to draft or revise SOPs, ensuring they are both technically robust and user-friendly.Quality Metrics Tracking: Compile and report on site-specific quality metrics (e.g., deviation cycle times, RFT rates) to the QA Ops Lead at HQ, providing visibility into site performance and compliance health.Material & Change Control Coordination: Coordinate on-site material releases and assist in the QA assessment of minor equipment or process changes to maintain the validated state of operations. qualifications: Required: B.S. in Biology, Chemistry, Engineering, or related field.Experience Gene & Cell Therapy experience, in a QA Operations roleQAnraw material experience.3-5 years of QA experience in the pharmaceutical/biotech industry.Strong understanding of FDA 21 CFR Part 210/211 and sterile manufacturing processes. Strongly Preferred: Gene Therapy/AAV experienceDrug Substance experience over Drug Product Experience #LI-TD1 skills: Data Analysis, Assay Development, Assay Method, Assay Verification, Data Management Plan, Deviation Management, CRO Oversight, Cross Functional Collaboration, Data Security and Privacy, Corrective and Preventive Actions (CAPA), Change Control Management, Quality Assurance (QA), Aseptic Processing, Biologics Manufacturing, Batch Record, Data Interpretation and Presentation, Quality Management Systems (QMS) 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 Randstad, 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 HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days.