Night-Shift Sterility Assurance Scientist

Insight Global; Concord (NC); On-site; USD 90,000 - 140,000; Full time

Job summary

Insight Global is seeking a Sterility Assurance Scientist (Night Shift) to support sterile/parenteral manufacturing operations. This role will provide hands-on guidance on aseptic processing, contamination control, and environmental monitoring while partnering with Operations, Quality, Environmental Monitoring, Engineering, and Technical Services on investigations, CAPAs, and process improvements.

The position requires deep GMP knowledge, experience in cleanrooms, and the ability to support 24/7

Qualifications

• Bachelor's degree in a scientific discipline as listed.
• 5+ years in pharmaceutical/biopharmaceutical manufacturing support.
• Experience in sterile/aseptic product manufacturing environments.
• Strong contamination control, sterility assurance, and environmental monitoring knowledge.
• Experience leading investigations, deviations, and CAPA activities.
• Hands-on GMP floor support and cross-functional collaboration.

Responsibilities

• Serve as on-the-floor technical resource for aseptic processing and sterility assurance.
• Support environmental monitoring, contamination control, and cleanroom best practices.
• Collaborate with Operations, Quality, Engineering, and Technical Services on investigations and CAPAs.
• Troubleshoot manufacturing issues and coach operators in aseptic techniques.

Skills

Sterility Assurance

Environmental Monitoring

Aseptic Processing

CAPA & Investigations

Root Cause Analysis

GMP Compliance

Cross-functional Collaboration

Floor-based Technical Support

Education

Bachelor's degree in Microbiology, Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline

Tools

TrackWise

Veeva Vault

Kneat

Pharmasuite

MODA

PI Vision

Job description

Insight Global is seeking a Sterility Assurance Scientist (Night Shift) to support sterile/parenteral manufacturing operations. This role will provide hands-on guidance on aseptic processing, contamination control, and environmental monitoring while partnering with Operations, Quality, Environmental Monitoring, Engineering, and Technical Services on investigations, CAPAs, and process improvements.

The position requires deep GMP knowledge, experience in cleanrooms, and the ability to support 24/7