About This Role:
As the QC Site EM/UM and Contamination Specialist, you will be an integral member of our Quality Control operations team at RTP Bio. Your expertise will be pivotal in managing and enhancing the Environmental Monitoring (EM) and Utility Monitoring (UM) programs at our site. You'll take on the mantle of a microbiology subject matter expert during manufacturing contamination events, ensuring that our products meet the highest quality standards. Your role involves periodic reporting on EM/UM data trends and spearheading remediation and improvement actions. By leading the Environmental Review Board, you maintain a comprehensive sampling schedule and scrutinize results for significant trends, contributing to our site's exemplary regulatory compliance. In this position, you will act as a vital link between the site Quality Leader and the Site Leadership Team, escalating any contamination quality concerns. In essence, you are the guardian of our site's sterility assurance, fitting seamlessly into our business structure and adding tremendous value through your critical contributions to product integrity and safety.What You’ll Do:Oversee the full spectrum of the site's EM/UM program and serve as the microbiology expert for manufacturing contamination events.Engage in periodic analysis and reporting of EM/UM data trends to inform remediation actions and continuous improvement initiatives.Lead the Environmental Review Board, manage the sampling schedule, and review results for meaningful trends, including sub-alerts.Escalate contamination quality concerns and potential inspection risks to the site Quality Leader and Site Leadership Team.Collaborate with QC validation, transfer, and registration (VTR) personnel to ensure implementation of regulatory, cGMP, and industry practices.Lead site investigations and provide remediation recommendations related to contamination events.Prepare subject matter experts (SMEs) for site inspection readiness and participate in audits, including response to observations.Educate, mentor, and guide site quality personnel on contamination control, sharing findings and lessons learned.Partner with Manufacturing Sciences and the Learning Organizations to develop site training and qualification programs for aseptic operations.Contribute to complex projects such as site disinfectant studies and contamination investigations.Represent QC during inspections for EM/UM program and contamination investigation topics.Provide oversight and expert support for EM/UM samplers.Network within the industry to benchmark and identify best practices for optimizing site contamination control processes.Foster a strong quality culture, maintain open communications, and promote teamwork within the workgroup.Who You Are:
You are a dedicated professional with a deep understanding of bioburden, endotoxin, and identity testing. Your knowledge of Annex 1 and site contamination control strategies is robust, and you contribute actively to complex projects and initiatives. In your career, you have honed your leadership skills and developed a keen technical understanding of contamination response from a compliance perspective. You stay current with technological and compliance developments in the industry. You are someone who values open communication, teamwork, and the importance of a strong quality culture in the workplace.
