Sterile Quality Assurance Specialist III

NCBioImpact; Greenville (NC); Sur place; USD 95 000 - 120 000; Plein temps

Résumé du poste

Thermo Fisher Scientific seeks a Quality Specialist III to provide quality oversight in the sterile lab, ensuring compliance with cGMPs and regulatory requirements while guiding documentation and procedures. You will help maintain quality across processes and projects in a dynamic environment.

The role emphasizes daily assessments, deviation investigations, change controls, and collaboration with cross-functional teams. Strong communication and proficiency with TrackWise/SAP are valued.

Qualifications

• Bachelor's degree in science or related field required.
• 5+ years of cGMP experience in the pharmaceutical industry.
• 2+ years in Quality Engineering, Compliance, or Regulatory Affairs.
• Experience in a cGMP environment is essential.
• Steriles manufacturing experience preferred.

Responsabilités

• Performs daily quality assessments of facility, personnel, and documentation.
• Provides internal and external customer support.
• Assists with aseptic technique and documentation corrections.
• Supports deviation events and change controls.
• Reviews procedures, training documents, and forms of moderate to high complexity.
• Participates in Root Cause Analysis to support deviation investigations.
• Engages in continuous improvement opportunities.
• Contributes to practical process improvement initiatives.

Connaissances

Quality oversight

cGMP compliance

Documentation writing

Root cause analysis

Interpersonal skills

Formation

BS/BA in a scientific field

Outils

TrackWise

SAP System

Description du poste

Thermo Fisher Scientific seeks a Quality Specialist III to provide quality oversight in the sterile lab, ensuring compliance with cGMPs and regulatory requirements while guiding documentation and procedures. You will help maintain quality across processes and projects in a dynamic environment.

The role emphasizes daily assessments, deviation investigations, change controls, and collaboration with cross-functional teams. Strong communication and proficiency with TrackWise/SAP are valued.