 Water SystemsPerform GMP reviews of microbiological testing data for facility and laboratory water purification systems, including LAL and bioburden results.Review analytical testing data for water systems, including TOC, conductivity, and EU WFI chemical testing.Review qualification and media release testing documentation.Review facility cleaning and in-process testing data such as endotoxin, bioburden, biological indicators (BI), HPLC, protein concentration, pH, and osmolality.Initiate and follow up on deviations when alert or action limits are exceeded, by established procedures.Support the preparation and completion of quarterly trend reports.Raw MaterialsConduct GMP reviews of raw material test data, including general appearance, identification, and FTIR results.Review testing data for house gas and air sampling.Initiate and follow up on out-of-specification (OOS) results and excursions beyond action limits per procedural requirements.Manage the electronic and physical receipt, log-in, and distribution of incoming QC samples and testing materials.Complete sample custody chains and ensure proper sample disposal.Prepare and ship samples or materials to internal and external labs.Perform aliquoting of bulk samples, assay standards, controls, and custom reagents.Laboratory SupportAssist in drafting, revising, and maintaining standard operating procedures (SOPs).Perform routine calibration and maintenance of laboratory equipment including pipettes, balances, plate readers, and pH meters.Clean incubators, biosafety cabinets, laminar flow hoods, refrigerators, and cold rooms; defrost freezers as needed.Prepare disinfectant solutions and maintain solvent wash bottles and water baths.Conduct regular GMP lab sweeps to maintain a compliant and orderly environment.Support investigations related to equipment out-of-tolerance (OOT) events and temperature excursions involving refrigerators, freezers, incubators, and pipettes.Review and maintain weekly Distributed Control System (DCS) documentation.Participate in investigations and tasks relevant to assigned responsibilities under the task order.
