Job Overview This role works with the process development (NPI) engineers to create quality control (QC) processes and transfer them into Operations. Works with the New Product Development (NPD) group as a subject matter expert (SME) for infectious disease IVD product development. Leads all quality control (QC) related to antibiotic resistance testing(ART) and antimicrobial susceptibility testing (AST) in vitro diagnostic (IVD) product manufacturing. The microbiologist creates procedures for maintaining bacterial stocks and using such stocks to perform QC testing. They also establish and own the bioburden testing program for the ISO 7 clean room.
Responsibilities Maintain bacterial stocks:Prepare and isolate antibiotic-resistant bacterial strains.Establish processes and perform validations on procedures for stock maintenance.Perform incoming QC procedures of bacterial stocks on bacterial culture materials (media, plates, etc.)Prepare bacterial cultures for testing and long-term storage.Monitor bacterial stocks for antibiotic resistance. Establish processes and perform validations on procedures for such.Create SOPs and processes for handling, plating, culturing, storing, and manipulation of BSL1 and BSL2 antibiotic-resistant bacterial strains.Monitor and train laboratory staff in microbiological processes with strict adherence to quality standards and good laboratory practices (GLP).Create, implement, and monitor processes for QC final release testing with bacterial strains for IVD products.Create, implement, and monitor processes for bioburden testing.Perform laboratory analysis on materials after appropriate sterilization.Perform tests on component samples, identify any contamination, conduct analysis, and initiate corrective measures.Perform audits on various environmental programs and perform reviews.Develop various testing processes for raw materials and equipment and monitor all finished products.Analyze and interpret QC data from AST IVDs to monitor for trends or issues.Education and Skills PhD in microbiology, medical or clinical microbiology, virology, clinical laboratory sciences, molecular biology, biochemistry, or similar background with at least 1-2 years of experience with microbiologic techniques.Or, Master's degree with 3-5 years of experienceOr, Bachelor's degree with 5+ years of experience in similar fieldsProficient in standard biology laboratory techniques, such as laboratory math, micropipetting, pH, buffer preparation, etc.Experience with antibiotic resistance and/or antimicrobial susceptibility testing strongly preferredExperience with bioanalytic and molecular biology techniques also preferred (ex. HPLC, mass spectroscopy, RT-PCR, NGS, ELISA etc.)Experience in a regulated environment or laboratory preferred (ex ISO 13485, ISO 11737, ISO 11133, ISO 17325, ISO 15189, FDA, or similar)Excellent communication skills, ability to summarize and report results t upper managementProficient in Microsoft Office Suite (Teams, Word, Excel, Powerpoint, etc.)Proficient in English (written and spoken) strongly preferred.
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