Nature and Scope The QC Environmental Monitoring Supervisor works with Environmental Monitoring (EM) Technicians in the activities associated with the manufacture of sterile pharmaceuticals in accordance with company Standard Operating Procedures (SOPs), Current Good Manufacturing Practices (cGMPs) and all other company policies. The Supervisor will liaise with manufacturing leadership to ensure the necessary support required by those areas is provided. The Supervisor will oversee the Environmental Monitoring (EM) program and will provide training, guidance, and support to EM Technicians. The Supervisor will coordinate day-to-day activities and the scheduling of EM Technicians and provide input and assistance to other departments as needed. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Ensure all work is performed and documented in accordance with existing company policies, SOPs, cGMPs, as well as health and safety requirements. Under the direction of Environmental Monitoring leadership, supervise the Environmental Monitoring program and EM team. Responsible for completing and maintaining gown qualification and gown training other staff members, where applicable. Provide technical and administrative support for all activities related to environmental monitoring, and documentation. Coordinates work projects with the Microbiology Management to appropriately schedule EM workload to meet department/site requirements. Schedule employees with respect to workload to improve efficiency. As required, assist EM technicians in sampling and other environmental monitoring responsibilities. Reviews SOPs as necessary, recommend changes, update and initiate change controls as needed. Review EM paperwork accuracy and completeness and submit to laboratory with plates for incubation in timely fashion. Issue and perform internal investigations, deviations or event reports and ensure the closure of such reports for nonconforming results, in a timely manner. Perform and maintain environmental monitoring tracking and trending of data in a timely manner and present report to Microbiology Management. Ensure and check the media and material inventory required for the environmental monitoring program and order supplies as necessary. Closely interact with and support manufacturing and quality personnel in all aspects of environmental monitoring. Ensure that the EM areas and EM laboratory is clean and sanitized. Assist leadership with timely completion of quarterly and other periodic projects and reports. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Bachelor's Degree in Microbiology, Biology, Environmental Sciences or related scientific field, required. Minimum of 8 years of experience in a pharmaceutical aseptic processing environment required; or MS Degree in Microbiology or related science with three (5) years pharmaceutical aseptic processing environment required. 1 to 3-years of leadership experience required and/or has demonstrated the ability to lead, coach or mentor a team or group. Previous experience working in environmental monitoring/sampling, writing EM protocols and EM investigations, water sampling, performing PQ of new EM and water systems, and gown qualification program, required. Experience with instruments such as LIMS, Met One, APC, air ideal, MAS 100, MAS 100 CG, Lighthouse System, or PMS system is required. Experience with systems such as Trackwise for Deviations, CAPAs and Veeva CR process, required. Experience in EMPQ, Water PQ, Environment