The primary focus area and scope of this position is characterization of biological materials and providing support to manufacturing with timely and accurate in-process and final product testing. The business departments (outside the immediate team) that this role will be working closely with on a regular basis are manufacturing, disease state procurement, and materials management.

To perform this job successfully, an individual must be able to capably perform each of the following essential functions: 

Primary duties

• Accurately perform routine testing with ELISA, immunoassays, bioburden, Western Blot, endotoxin and sterility testing, and other test methods on infectious and non-infectious raw material samples and finished biological products.
• Analyze and record testing data with a focus on accuracy with the awareness that timely work impacts other groups to meet critical customer deadlines.  
• Perform routine clean room environmental monitoring and water system sampling.
• Ensure testing equipment is calibrated prior to use.
• Perform weekly and monthly preventative maintenance to ensure equipment is working properly.
• Maintain an accurate electronic database of sample submission, testing, and final disposition.
• Produce and use control charts. Perform tracking and trend analysis on laboratory data. 
• Performs quality control duties including, but not limited to; daily temperature log entries, emptying biohazard trash, etc.
• Document technical problems, report problems to Supervisor.
• Maintain a high quality of work that has the potential to impact valuable product results, which are critical to customers.
• Enter test results into an electronic database, scan and file the paper record.
• Adherence to company Standard Operating Procedures, as well as, regulatory agencies and customer requirements.
• Comply with cGMP and ISO standards at all times to support LGC’s commitment to Quality.
• Assist with the implementation of corrective actions in response to internal and external audits.
• Maintain the appearance of the QC lab on a daily basis for audit readiness.
• Follow Operational Excellence principles, e.g. removal and disposal of expired chemicals and reagents, removal of broken equipment and unused equipment and supplies from the laboratory.
• Perform other duties as required, or assigned by management, to meet business needs.