Quality Control Lab Associate Specialist

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

Join a world-class Quality group dedicated to delivering a safe, compliant, and reliable supply of biopharmaceuticals worldwide. As a Quality Control Lab Associate Specialist, you will play a vital role in product quality assurance by performing microbiological, chemical, and analytical sampling and assays. Working closely with cross-functional teams in Production, Quality Assurance, Validation, and Facilities, you will execute critical environmental and water systems monitoring to support ongoing manufacturing and help bring life-saving medicines to patients.

Responsibilities

• Conduct routine environmental monitoring (EM) sampling, including active air, surface, and water systems testing across manufacturing areas.
• Perform in-process and finished product release testing, including sterility testing, residual moisture detection, and average cell dry weight testing.
• Apply aseptic techniques strictly while handling biological samples, evaluating microbiological cultures, and executing assays.
• Adhere strictly to Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (cGMPs) across all lab activities and documentation.
• Collaborate with colleagues to identify and resolve technical or operational shop-floor issues guided by established policies and procedures.
• Evaluate experimental and environmental data, assist with report writing, troubleshoot assays, and participate in process improvement projects.
• Interact cross-functionally with Quality Assurance, Validation, Facilities, and Production teams to support seamless lab and plant operations.
• Maintain clear communication, ask clarifying questions, and ensure alignment with department objectives and next-level management.

Education

• Bachelor's degree in Biology, Microbiology, Biochemistry, or a related scientific field; OR
• Associate's degree in Biology, Microbiology, Biochemistry, or a related field plus 1–2 years of relevant laboratory or pharmaceutical industry experience.

Experience

• Demonstrated understanding and practical application of GLPs, cGMPs, and aseptic technique.
• Hands-on experience performing environmental monitoring and water systems sampling in a regulated environment.
• Proven ability to work effectively within a collaborative, cross-functional team setting.
• Preferred experience utilizing laboratory and production software systems such as LIMS or SAP.
• Preferred strong written and verbal communication skills for data reporting and interdepartmental collaboration.

Additional Information

• Shift Details: 1st Shift Days (Tuesday – Saturday); weekends required.
• Working Hours: 8:30 AM – 5:00 PM (8-hour shift with a 30-minute lunch break), with flexibility for earlier or later start times based on Environmental Monitoring needs.
• Role Impact: Shop-floor decision-making accountability guided by established SOPs and regulatory standards.