Nature and ScopeThe QC Environmental Monitoring Lead works with Environmental Monitoring (EM) team in the activities associated with the manufacture of sterile pharmaceuticals in accordance with company Standard Operating Procedures, cGMPs and all other company policies. The EM Lead with interphase with EM Supervisor and EM Team to ensure the necessary support required by production areas is provided. The EM Lead will help Supervisor to oversee the environmental monitoring program and will provide training, guidance, and support to EM team under Supervision. The Lead will coordinate scheduling of EM team and provide input and assistance to EM Supervisor and other departments as needed.Essential Duties and ResponsibilitiesNothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.Under the direction of the EM Supervisor oversee the environmental monitoring program and EM team.Lead and support gown qualification and gown training of other staff members, where applicable.Support EM Supervisor to provide technical and administrative support for all activities related to environmental monitoring, and documentation.Appropriately schedule EM workload to meet department/site requirements under Supervision.Schedule employees with respect to workload to improve efficiency for EM and Water Sampling.As required assist EM team in sampling and other environmental monitoring responsibilities.Use TrackWise/VeeVa to initiate change controls and review SOP's as necessary, recommend changes, updates and as needed.Assists Environmental Monitoring Supervisor to ensure EM team for their respective shift are current on all training requirements.Review EM Worksheets/MODA/LIMS for accuracy and completeness and submit to Microbiology laboratory.Using TrackWise- Issue and perform investigations, deviations or event reports, CAPA and ensure the closure, in a timely manner.Ensure all tasks are completed for their respective shift and convey any discrepancies to Environmental Monitoring Supervisor.Ensure all changes within Production Schedule are conveyed across all shifts.Track the inventory of the media and material 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.Assist EM Supervisor with timely completion of quarterly and other periodic projects and reports.Perform any other tasks/duties as assigned by management.Education Requirements and QualificationsTo 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.High School Diploma or GED equivalent required. Associate Degree in microbiology, biology or related scientific field preferred.Minimum of 4 years experience in a pharmaceutical aseptic processing environment, medical device, beverage or food microbiology industry required.Previous experience working in environmental monitoring/sampling, writing EM protocols and EM investigations, water sampling,and leadinggown qualification program required. Previous experience in performing PQ of new EM and water systems is preferred.Experience with operation of instruments like Met One, air ideal, SAS, MAS 100, MAS 100 CG, Lighthouse System, or PMS system is required.Minimum 2 years of Environmental Monitoring floor experience preferred with consistency on time and task deliverability.Strong understanding of Aseptic Technique, Aseptic Behavior, and Quality Culture.Must be able to maintain Class 100 Certification for EM supportAbility to train and teach EM Team.Trending of EM and Water dataExcellent computer skills and proficient in Microsoft Word, E