QC Sampling Specialist

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

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 100 years, we continuously innovate to improve the diagnosis, prognosis and quality of life of patients.

Customer Centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team with nearly 3,000 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging.

WHAT WE ARE LOOKING FOR

The QC Sampling Specialist will operate in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for. The QC Sampling Specialist performs environmental, utilities, and product sampling in a GMP-regulated environment, ensuring compliance with approved procedures, aseptic techniques, and regulatory requirements. The role supports contamination control by conducting sampling in classified areas while adhering to strict gowning and aseptic practices. Working closely with QC Microbiology, Production, and QA, the specialist ensures reliable, compliant, and high-quality sampling activities.

YOUR ROLE

• 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

Department Specific/Non-Essential Functions:

• Participate in investigations related to environmental monitoring or utilities results
• Contribute to improvements in sampling procedures and contamination control practices
• Support training activities related to sampling techniques and cleanroom behaviors
• Assist with internal and external audits related to sampling activities
• Performs other duties as assigned by management

YOUR BACKGROUND

Required Qualifications

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

Preferred Qualifications

• Experience performing sampling in aseptic or Grade A/B cleanroom environments
• Familiarity with Annex 1 expectations for environmental monitoring and contamination control strategies
• Experience supporting regulatory inspections or audit readiness activities related to microbiology or sampling
• Experience trending or reviewing environmental monitoring or utilities data
• Familiarity with electronic systems such as LIMS or environmental monitoring data systems
• Prior experience in sterile manufacturing or biologics environments