The QC Scientist-Microbiology is responsible for day to day operations of the QC Microbiology laboratory in a cGMP biopharmaceutical pilot plant. The individual prioritizes, oversees, and tracks multiple microbiological projects ensuring timely completion and efficient utilization of staff and equipment. The QC Scientist is responsible for leading and/or collaborating in the routine operation of the microbiology lab. The individual provides technical expertise and trains other analysts on microbiological analyses. The QC Scientist has responsibility for maintaining analytical instruments, using knowledge and experience to appropriately respond to malfunctions, scheduling, monitoring, and interfacing with external personnel as necessary. In addition to prioritizing overall workflow, analyst training and equipment maintenance, the individual provides technical expertise, generates compliant laboratory data for release, validation of assays as appropriate and support of critical utility, environmental and process stream testing. The QC Scientist serves as a first-line resource to other analysts in assessing and resolving technical issues. The QC Scientist authors and updates SOPs for laboratory procedures, and operation of equipment, investigates and documents microbiology alert/actions, OOS/OOT events and implements the appropriate CAPA when necessary. The QC Scientist is responsible assisting with routine trending of critical utilities and environmental monitoring results.
* Experience in Biopharmaceutical industry required
* Proficiency gained through wide exposure / experience in technical field; broad grasp and application of scientific theory and principles
* Expert working experience with microbiological testing such as membrane filtration and direct plating bioburden, endotoxin testing using kinetic chromogenic systems, microbial identifications and environmental monitoring experience using viable and non-viable methods.
* Strong experience with designing and executing microbial studies and investigations required.
* Strong experience with independent validation of microbial instrumentation required.
* Experience with aseptic technique, TOC and conductivity is required
* Ability to perform repetitive tasks while maintaining speed of work and attention to detail.
* Strong working knowledge of cGMP/ICH/FDA/EMEA regulations and guidelines
* Proficient in MS Office applications; particularly Excel graphing.
* Experience with statistical software such as Minitab© or JMP