Responsible for performing Quality Control Testing, Shelf-Life Testing, and Packaging Event Evaluations on Microbiologics products in accordance with the appropriate Company Device Master Record (DMR), policies and procedures with the objective to release only production products that meet all of Microbiologics acceptance criteria. Specific duties include: Performs virology (subfield of microbiology) techniques including but not limited to titration by TCID50, microscopic observations of CPE, virus specific antibody staining, and PCR to monitor growth. Works cross-functionally with Cell Systems and Virology to verify sterility and inactivation of materials used in research, product development, and production. Leads training on virology tasks for QC Technicians and Microbiologists as needed. Performs Sanger sequencing, including genomic isolation, purification, and sequencing. Leads or designs special projects as needed including but not limited to: writing procedures, performing validations, performing DCRs and completion of non-conforming work investigations. Performs molecular biology techniques including but not limited to PCR, gel electrophoresis, and nucleic acid quantitation. Performs Quality Control Testing on Microbiologics products including clinical, pharmaceutical, and molecular products which are tested in accordance with appropriate DMR. Ensures identification and traceability of material. Inspects equipment, structures, or materials to identify the cause of errors or other problems or defects. Analyzes information and evaluates results to choose the best solution and solve problems. Maintains familiarity with Microbiologics product inserts, technical manual, and current Clinical and Laboratory Standards Institute (CLSI) and government regulations. Performs maintenance per General Maintenance Schedule when applicable. Responsible for documentation as it applies to the QMS regarding the provisions of quality assurance and laboratory service. Requires Bachelor s Degree in Biomedical Sciences, Microbiology, or a related field. Must have 4 years of experience including: Minimum of 4 years of practical microbiology laboratory experience. Minimum of 4 years of experience with multiple commercial diagnostic platforms. Minimum of 4 years of experience with BSL2 and BSL2+ laboratory procedures. Minimum of 3 years of experience with molecular biology techniques with a technical understanding and hands-on experience with molecular biology and Sanger sequencing. Minimum of 2 years of hands-on experience with virology techniques. Multiple openings.