QA Specialist III (QOTF) - 12 Hour Days (2-2-3 shift)

Thermo Fisher Scientific seeks a QA Specialist III to provide hands-on quality oversight of sterile pharmaceutical manufacturing operations in Greenville, North Carolina. This role combines floor-based observation, real-time guidance to production personnel, and compliance monitoring across filling, packaging, and inspection activities on a 12-hour rotating day shift.

Responsibilities

• Conduct daily Quality Assurance oversight of sterile manufacturing, filling, packaging, and inspection activities
• Perform documented floor walkthroughs to assess facility conditions, equipment, personnel practices, and production documentation
• Observe manufacturing and provide real-time coaching and guidance to operators and production leadership
• Identify, document, and escalate quality concerns, compliance gaps, and operational risks
• Participate in deviation investigations, root cause analysis, and continuous improvement activities

Requirements

• Experience in pharmaceutical manufacturing quality assurance or operations
• Knowledge of cGMP requirements and aseptic manufacturing practices
• Ability to lift 40 pounds and work in cleanroom environments
• Strong documentation review and batch record assessment skills
• Problem-solving abilities and interpersonal communication skills
• Comfort with routine floor walkthroughs and operational observation