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 dutiesAccurately 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.
