QC Sampling Specialist (Raleigh, US)

NCBiotech; Raleigh (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

Guerbet, a global leader in medical imaging, is seeking a QC Sampling Specialist to perform environmental, utilities, and product sampling in a GMP environment. You will work closely with QC Microbiology, Production, and QA to ensure reliable, compliant sampling activities.

The role requires an associate degree or technical training in microbiology or a related science, experience in GMP settings, and knowledge of cleanroom aseptic techniques.

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.

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

GMP experience

Environmental monitoring

Aseptic techniques

Education

Associate’s degree or technical training in microbiology, biology, biotechnology, or a related scientific discipline

Job description

QC Sampling Specialist

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 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

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

Reason to join US

Much more than a Competitive salary,

We offer continued personal development. When you join Guerbet, you :

• Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,
• Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,
• Are joining a company where we value diversity of talents coming from various horizon.

We # Innovate # Cooperate # Care #Achieve at Guerbet.

Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to [e-mail] or you can also call this number [phone]