Sterility Assurance Scientist - Night Shift Aseptic Expert

Virtue America; North Carolina; On-site; USD 90,000 - 120,000; Full time

Job summary

Virtue America is seeking two experienced Sterility Assurance Scientists for night-shift roles on a rotating 12-hour schedule. The positions involve hands-on aseptic pharma manufacturing support, working with QA, Environmental Monitoring, and Technical Services to ensure sterility and contamination control.

Initial training occurs on days, with full responsibilities on nights. The role requires a Bachelor's degree in a related science and hands-on GMP sterile manufacturing experience, plus

Qualifications

• GMP-regulated sterile manufacturing experience required.
• Aseptic processing and contamination-control knowledge essential.
• Experience with deviation investigations and CAPA processes preferred.
• Comfortable working in cleanrooms and rotating night shifts.
• Strong data analysis and problem-solving skills required.

Responsibilities

• Provide manufacturing-floor support for aseptic and sterile production.
• Monitor gowning, aseptic techniques, and contamination-control procedures.
• Troubleshoot manufacturing issues and coach operators on aseptic practices.
• Lead deviation investigations, root-cause analysis, and CAPA activities.
• Support environmental monitoring, smoke studies, EMPQs, and bioburden qualifications.
• Assist with isolator glove integrity testing, cleaning, and validation studies.

Skills

GMP sterile manufacturing

Aseptic processing

Environmental monitoring

CAPA investigations

Troubleshooting

Night-shift capability

Education

Bachelor's degree in Microbiology/ Biology/ Chemistry/ Biochemistry/ Pharmaceutical Sciences

Tools

Veeva Vault Quality

TrackWise

Kneat

Isolator systems

Job description

Virtue America is seeking two experienced Sterility Assurance Scientists for night-shift roles on a rotating 12-hour schedule. The positions involve hands-on aseptic pharma manufacturing support, working with QA, Environmental Monitoring, and Technical Services to ensure sterility and contamination control.

Initial training occurs on days, with full responsibilities on nights. The role requires a Bachelor's degree in a related science and hands-on GMP sterile manufacturing experience, plus