TSMS Sterility Assurance Scientist

QCS Staffing; North Carolina; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

Job summary

QCS Staffing Ltd is seeking a TSMS Sterility Assurance Scientist for a US North Carolina project. The role focuses on embedded support in the Sterility Assurance Process Team, coaching operators, auditing aseptic practices, and ensuring clean room integrity.

The candidate will troubleshoot process issues, lead remediation activities, and collaborate with quality, engineering, and leadership to ensure compliance with cGMP manufacturing standards.

Qualifications

• Bachelor’s degree in microbiology, chemistry, biology, biochemistry, pharmaceutical sciences or related field.
• Experience with manufacturing parenteral drug products and aseptic processing environments.
• Experience troubleshooting manufacturing issues and performing root cause analysis.

Responsibilities

• Provide hands-on guidance to operators in aseptic areas and coach staff on aseptic practices.
• Troubleshoot process issues, lead remediation activities, and manage unplanned events.
• Escalate issues to appropriate technical or leadership resources and support safety programs.

Skills

Microbiology

cGMP manufacturing

Root cause analysis

CAPA execution

Education

Bachelor’s degree in microbiology or related

Job description

TSMS Sterility Assurance Scientist – US, North Carolina – Initial 12-Month Contract – Life Sciences

Be part of a next-generation pharmaceutical project that’s transforming how medicines are made. We’re supporting a major new-build facility in North Carolina, a multi-billion-dollar investment designed to push the boundaries of science and engineering. We’re looking for a TSMS Sterility Assurance to support this project and help deliver this world‑class program.

What you’ll deliver:

• Serve as an embedded resource and extension of the Sterility Assurance Process Team, providing hands‑on guidance to operators and manufacturing personnel during production and spending the majority of the shift coaching, auditing, and communicating within the aseptic processing areas.Monitor and reinforce best aseptic practices within classified areas; identify and report events affecting the maintenance of aseptic conditions in clean rooms; correct improper aseptic technique when observed and communicate corrected behaviors to supervisors.
• Troubleshoot process issues and respond to unplanned or unexpected events in classified areas, including events requiring aseptic interventions; lead and organize remediation activities (i.e. recovery cleaning, alarm response, etc.) from day‑to‑day unplanned events and shutdowns.
• Recognize when issues require escalation and engage the appropriate technical, quality, engineering, or leadership resources.
• Ensure a safe working environment through compliance with safety rules and active participation in safety‑related activities.

What you’ll need:

• Bachelor’s degree in microbiology, Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or another relevant scientific or technical discipline.
• Demonstrated understanding and relevant experience of scientific principles required for manufacturing parenteral drug products within operations, microbiology, environmental monitoring, sterility assurance, validation, technical services, and/or quality assurance associated cGMP pharmaceutical manufacturing.
• Experience owning or providing sustained, hands‑on technical support of a manufacturing process or product line through ongoing commercial or scale‑up production.
• Direct experience troubleshooting manufacturing issues, investigating manufacturing deviations, performing root cause analysis, and supporting CAPA development and execution.
• Experience mentoring scientists, technicians, and/or manufacturing operators.