Job Details

Quality Assurance SpecialistPrimary Skills: cGMP Compliance (advanced), Deviation Investigation (advanced), Aseptic Technique (intermediate), Technical Writing (intermediate), Process Improvement (intermediate) Contract Type: W2 Duration: 10 Months Location: Greenville, NC Pay Range: $51.50/hr - $56.50/hr Shift: 6 PM - 6 AM (2-2-3 rotation) Job Summary: Drive quality execution across sterile operations including manufacturing, filling, packaging, and inspection for commercial and product development services. Provide quality guidance for process improvements. Hours: 6p-6a, 2-2-3 rotation.Key ResponsibilitiesPerform daily quality assessments of facility, personnel, and documentation to ensure compliance with cGMPsInteract with employees on troubleshooting, documentation, and aseptic technique guidanceChampion quality culture and support continuous improvement initiativesParticipate in deviation event response and Root Cause AnalysisReview and approve procedures, training documents, deviations, and change controlsPerform quality batch record reviewMust-Have SkillsBachelor's degree in technology, engineering, or microbiology4+ years in Quality Assurance, Quality Control, or ManufacturingData analysis and troubleshooting expertiseStrong ownership and leadership abilitiesTechnical writing experiencePhysical ability to work production floor (standing, walking, bending for prolonged periods)Industry ExperiencePharmaceutical industry experience with aseptic/sterile processes strongly preferredOther regulated environments (e.g., ISO 9001) consideredProfessional certifications (CQA) and Six Sigma training a plus