Quality Assurance Specialist : 26-03046

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 Responsibilities

• Perform daily quality assessments of facility, personnel, and documentation to ensure compliance with cGMPs
• Interact with employees on troubleshooting, documentation, and aseptic technique guidance
• Champion quality culture and support continuous improvement initiatives
• Participate in deviation event response and Root Cause Analysis
• Review and approve procedures, training documents, deviations, and change controls
• Perform quality batch record review

Must-Have Skills

• Bachelor's degree in technology, engineering, or microbiology
• 4+ years in Quality Assurance, Quality Control, or Manufacturing
• Data analysis and troubleshooting expertise
• Strong ownership and leadership abilities
• Technical writing experience
• Physical ability to work production floor (standing, walking, bending for prolonged periods)

Industry Experience

• Pharmaceutical industry experience with aseptic/sterile processesstrongly preferred
• Other regulated environments (e.g., ISO 9001) considered
• Professional certifications (CQA) and Six Sigma training a plus