Environmental Monitoring and Utilities Monitoring Technical Support, Quality Control Microbiolo[...]

Job DescriptionEM/UM Technical Support, Quality Control MicrobiologyGeneral Summary:The Environmental Monitoring and Utilities Monitoring Technical support role will provide technical support for EM/UM team as a Subject Matter Expert (SME). This role will serve as a key resource within the organization, providing technical expertise in the areas of EM/UM sampling, testing, aseptic processing, and contamination control in accordance with regulatory standards. This role reports to the Associate Director of Quality Control in Cell and Genetic Therapies (VCGT).On site role.12 month contract with the chance to extend.Key Duties and Responsibilities:Demonstrates a strong understanding of sampling and microbiological testing methodologies including but not limited to EM, UM, Bioburden, Endotoxins, Sterility, Gram Stain, and Identification program per relevant regulatory standardsHands-on experience in the handling of microbiology lab instruments i.e. Vitek, Endosafe, BacT, MALDI-TOF, IsolatorOrganize, plan, and support team members with technical questions and problem-solving to ensure group efficiency and accountabilityEnsure compliance with current Good Manufacturing Practices (cGMP), as well as Health, Safety, and Environmental policies per Vertex standardsProvide subject matter expertise in Out-of-Specification (OOS) and Out-of-Trend (OOT) investigationsManages deviations and Corrective and Preventative Action (CAPA) implementation associated with Microbiological methodologiesSupport laboratory inspections and audits, including addressing follow-up actions and ensuring continuous improvementCollaborate with cross-functional teams, including Manufacturing, Quality Assurance, Regulatory CMC, and Analytical Development, to ensure alignment and effective communication between teamsProvide guidance in drafting EM/UM Trend ReportsAssist with document revisions.Knowledge and Skills:Extensive knowledge and experience of Quality Control methods and compendial requirements including but not limited to (Sterility, Endotoxin, Environmental monitoring, ID, APS/PAQ processes)Strong understanding of Aseptic processing and contamination control strategies in manufacturing facilitiesExtensive experience working in a GMP environmentStrong communication and scientific writingStrong project management skillsExperience with electronic systems such as LIMS and Quality Management Systems (Veeva) preferredEducation and Experience:Bachelor's degree in Microbiology or related field.A minimum of 7 years of industry experience in Microbiology in a Biotechnology and/or Cell and Gene therapy organization.Pay Range$60-$70/HRJ-18808-Ljbffr