Biopharma QC Lab Specialist – Microbiology & EM

WorkLLama; Durham (NC); On-site; USD 55,000 - 75,000; Full time

Job summary

WorkLLama is seeking a Quality Control Lab Associate Specialist in Durham, NC, to perform microbiological, chemical, and analytical sampling and assays. You will conduct environmental monitoring and support ongoing manufacturing, ensuring compliance with GLPs and cGMPs.

You will collaborate with Production, QA, Validation, and Facilities to resolve issues, write reports, and drive continuous improvement while maintaining strict communication and adherence to SOPs.

Qualifications

• GLPs and cGMPs knowledge required.
• Experience with environmental monitoring and water sampling in a regulated environment.
• Strong written and verbal communication for data reporting.

Responsibilities

• Perform routine environmental monitoring (EM) sampling across manufacturing areas (air, surface, water).
• Conduct in-process and finished product release testing including sterility, residual moisture, and average cell dry weight testing.
• Apply aseptic techniques while handling biological samples and evaluating cultures.
• Adhere to GLPs and cGMPs across lab activities and documentation.
• Collaborate with QA, Validation, Facilities, and Production to resolve shop-floor issues.
• Evaluate data, assist with report writing, troubleshoot assays, and participate in process improvements.
• Interact with cross-functional teams to ensure alignment with department objectives.

Skills

GLP compliance

cGMPs

Aseptic technique

Environmental monitoring

Lab instrumentation

Education

Bachelor's degree in Biology/Microbiology/Biochemistry or related field

Associate's degree + 1-2 years relevant lab experience

Tools

LIMS

SAP

Job description

WorkLLama is seeking a Quality Control Lab Associate Specialist in Durham, NC, to perform microbiological, chemical, and analytical sampling and assays. You will conduct environmental monitoring and support ongoing manufacturing, ensuring compliance with GLPs and cGMPs.

You will collaborate with Production, QA, Validation, and Facilities to resolve issues, write reports, and drive continuous improvement while maintaining strict communication and adherence to SOPs.