QA Specialist

QA Specialist - Zebulon, NC (On-site)We are hiring a QA Specialist to join a global pharmaceutical organization at its Zebulon, NC facility, supporting the quality and compliance of Investigational Medicinal Products distributed worldwide.This is a full-time, on-site position (first shift, 8:00 am to 5:00 pm).Key Responsibilities:Serve as Batch Release Officer, reviewing and recommending release of documentation for dosage form batches and finished clinical trial packs, in line with GMP requirementsAssess Quality QMS records (deviations, internal and third-party complaints) and recommend corrective and preventive actionsReview and approve GMP documentation (SOPs, Change Controls, and other controlled documents) from business partner areas such as Clinical Supply Chain packaging and logisticsProvide quality-related advice and support to business partner areasContribute to the development of processes and procedures within Quality R&D Supply QA/QP USParticipate in audits/assessments, regulatory inspections, and high-priority projectsLead or contribute to continuous improvement initiativesRequired:Bachelor's degree or equivalent experience (5+ years in a similar role)QA review experience with GMP manufacturing/packaging documentation and/or laboratory records for pharmaceutical dosage forms (sterile products a plus)Solid working knowledge of GMP principles, with proven decision-making based on this knowledgeExperience leading or participating in QMS activities (deviations, complaints, change controls, inspections/audits, root cause analysis)Proficiency with Microsoft Office (Word, Excel, PowerPoint)Preferred:Experience working in high-pressure environments with competing prioritiesKnowledge of R&D processes, particularly clinical trials manufacturing and packagingStrong attention to detailExcellent communication skills and ability to build trust-based relationships