Quality Control Lab Associate Specialist

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.