Night Shift Aseptic Sterility Assurance Scientist

Insight Global; Concord (NC); Vor Ort; USD 110.000 - 140.000; Vollzeit

Zusammenfassung

Insight Global is seeking a Sterility Assurance Scientist (Night Shift) to support sterile/parenteral manufacturing operations. The role acts as a technical resource on the manufacturing floor, guiding aseptic processing, contamination control, environmental monitoring, and cleanroom best practices.

Responsibilities include investigations, CAPAs, and process improvements while partnering with Operations, Quality, Engineering and Technical Services to ensure compliance with GMP and aseptic

Qualifikationen

• Bachelor's degree in a scientific discipline (Microbiology/Biology/Chemistry/Biochemistry/Pharmaceutical Sciences)
• 5+ years of experience in pharmaceutical/biopharmaceutical manufacturing
• Experience in sterile, aseptic, parenteral, or injectable product manufacturing
• Strong understanding of contamination control and sterility assurance
• Experience with investigations, root cause analysis, deviations, and CAPA activities
• Hands-on GMP manufacturing support on the floor
• Cross-functional collaboration with Manufacturing, Quality, Engineering, and Operations
• Ability to work in cleanroom environments and provide floor-based support

Aufgaben

• Support sterile/parenteral manufacturing operations on the floor.
• Provide hands-on technical guidance on aseptic processing and sterility assurance.
• Collaborate with Operations, Quality, Environmental Monitoring, Engineering and Technical Services.

Kenntnisse

Aseptic processing

Sterility assurance

Environmental monitoring

CAPA investigations

Root cause analysis

GMP manufacturing

Cross-functional collaboration

Cleanroom operations

Floor-based troubleshooting

Ausbildung

Bachelor's degree in Microbiology / related science

Tools

TrackWise

Veeva Vault

Kneat

Pharmasuite

PI Vision

MODA

Jobbeschreibung

Insight Global is seeking a Sterility Assurance Scientist (Night Shift) to support sterile/parenteral manufacturing operations. The role acts as a technical resource on the manufacturing floor, guiding aseptic processing, contamination control, environmental monitoring, and cleanroom best practices.

Responsibilities include investigations, CAPAs, and process improvements while partnering with Operations, Quality, Engineering and Technical Services to ensure compliance with GMP and aseptic