Senior QC Microbiologist

Primary Duties:The Quality Control Microbiologist will be primarily responsible for sampling and testing of clean utilities and clean rooms to support the commissioning, qualification, and startup of a new manufacturing facility, the Gene Therapy Innovation Center (GTIC).  Other responsibilities will include conducting method qualification, method suitability testing, validation and routine testing of microbiological and compendial assays in compliance with all applicable quality systems and current cGMPs within the Quality Control Operations organization.  They will support the departmental goals and contribute to general operations of the microbiology laboratory.   This role will contribute to the development and implementation of new programs that govern general and microbiology specific laboratory practices, participate in OOS and Alert / Action Investigations, generate deviation documentation and trend reports, and assist with audit preparation and participation. They will author, review, and revise SOP’s, reports, technical documents, and attend cross-functional team meetings as a QC Microbiology representative.In addition, the Quality Control Microbiologist will perform cGMP testing to support microbiological testing of raw materials, in-process, finished product, and stability samples. Testing will include but is not limited to: environmental monitoring and plate reads, gowning qualification, endotoxin, bioburden. They will ensure compliance with current regulatory requirements (USP, EU, ISO, ICH and FDA guidance), good documentation practices (cGDP) and industry best practices for manufacturing (cGMP).Job Description:Train on assigned SOPs and perform OJT/Qualification as applicablePerform environmental monitoring (EM), which requires gowning qualification, routine EM sampling, plate incubation/enumerationSupport method transfers and method qualification/suitabilityPerform required on-site microbiology, compendial, and raw material testing, which includes but not limited to:  Bioburden, Endotoxin, ID, Growth Promotion, pH, Osmolality, and Appearance.Participate in laboratory investigations, deviation investigations.Identify areas for continuous improvement and complete document revisions.Author and Lead Technical Protocols and Technical ReportsData entry, scanning, filing, and trendingOrder QC supplies to support testingInitiate Work Order as required for laboratory equipmentRepresent the department in cross functional meetings and projects