GMP QC Sampling Specialist - Env & Utilities

Guerbet; Raleigh (NC); On-site; USD 70,000 - 100,000; Full time

Job summary

Guerbet in Raleigh, NC, seeks a QC Sampling Specialist to perform environmental monitoring and sampling in a GMP environment. You will handle surface, air, and personnel checks, ensuring aseptic techniques and contamination control while coordinating with production.

Responsibilities include utilities sampling, sample collection, labeling, and documentation to ALCOA+ standards. You will support investigations, audits, and training to maintain high-quality sampling processes.

Qualifications

• Associate degree or technical training in microbiology, biology, biotechnology, or a related scientific discipline.
• Experience in a GMP pharmaceutical, biotech, or sterile manufacturing environment.
• Experience with environmental monitoring or utilities sampling.
• Knowledge of cleanroom operations and aseptic techniques.

Responsibilities

• Perform routine environmental monitoring (EM) sampling in classified manufacturing areas according to approved plans.
• Conduct surface, air, and personnel monitoring using appropriate sampling techniques and equipment.
• Execute sampling activities using proper aseptic techniques while adhering to contamination control and cleanroom gowning requirements.
• Perform utilities sampling (e.g., purified water, WFI, gases) in accordance with approved procedures.
• Collect in-process and product samples while ensuring representativeness and minimizing contamination risk.
• Coordinate with manufacturing to perform sampling without disrupting operations.
• Ensure accurate sample identification, labeling, traceability, and timely transfer to the QC laboratory.
• Complete sampling documentation in compliance with GMP, GDP, and data integrity (ALCOA+) requirements.
• Follow all approved procedures related to sampling and contamination control.
• Report deviations, atypical observations, or potential contamination risks.
• Performs other duties as assigned by management.
• Participates in investigations related to environmental monitoring or utilities results.
• Contributes to improvements in sampling procedures and contamination control practices.
• Supports training activities related to sampling techniques and cleanroom behaviors.
• Assists with internal and external audits related to sampling activities.

Skills

Env monitoring

GMP environment

Aseptic techniques

Contamination control

Sampling procedures

Documentation

ALCOA+

Audit readiness

Education

Associate degree

Tools

LIMS

Job description

Guerbet in Raleigh, NC, seeks a QC Sampling Specialist to perform environmental monitoring and sampling in a GMP environment. You will handle surface, air, and personnel checks, ensuring aseptic techniques and contamination control while coordinating with production.

Responsibilities include utilities sampling, sample collection, labeling, and documentation to ALCOA+ standards. You will support investigations, audits, and training to maintain high-quality sampling processes.