QC Sampling Specialist
About The Position
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.
Requirements
- 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
Nice To Haves
- 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
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
- 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
Benefits
- Continued personal development
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
