Sterility Assurance Scientist

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

Position: Sterility Assurance Scientist - Night Shift (2 Openings)

Duration: 12+ Months

Hours: 40 hours/week

Schedule: Rotating 12-hour shifts (2-2-3 schedule), primarily nights; initial training on day shift

Job Description

We are seeking two experienced Sterility Assurance Scientists to provide hands-on technical support for aseptic pharmaceutical manufacturing and sterile parenteral drug production. The role involves working closely with Manufacturing, Quality Assurance, Environmental Monitoring, and Technical Services to maintain sterility assurance and contamination control.

Key Responsibilities

• Provide manufacturing-floor support for aseptic processing and sterile production.


• Monitor gowning practices, 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, APS/media fills, EMPQs, and bioburden qualifications.


• Assist with isolator glove integrity testing, cleaning, sanitization, and validation studies.


• Analyze manufacturing and microbiological data and support continuous improvement initiatives.

Required Skills

• Hands-on experience in GMP-regulated sterile pharmaceutical or biopharmaceutical manufacturing.


• Strong knowledge of aseptic processing, microbiology, environmental monitoring, and contamination control.


• Experience with deviation investigations, root cause analysis, and CAPA.


• Manufacturing-floor troubleshooting and operator coaching experience.


• Ability to work in classified cleanrooms and rotating 12-hour night shifts.

Preferred Qualifications

• 5+ years of relevant pharmaceutical manufacturing experience.


• Experience in Sterility Assurance, MSAT/MS&T, Environmental Monitoring, or Parenteral Operations.


• Knowledge of APS/media fills, smoke studies, EMPQs, and isolator systems.


• Familiarity with Veeva Vault Quality, TrackWise, or Kneat.

Education: Bachelor's degree in Microbiology, Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or a related discipline.

Candidates must and should provide 2 Manager-level professional references along with their resume for consideration.