Environmental Monitoring Specialist

SUMMARY:The Environmental Monitoring Specialist will perform all tests required to monitor the manufacturing controlled areas at Akorn''s Grand Avenue facility. In addition, they will provide support for efforts designed to evaluate the effectiveness of environmental monitoring controls used in the manufacture of sterile pharmaceuticals. This individual will work well with minimal supervision and report directly to the Environmental Monitoring Supervisor. ESSENTIAL FUNCTIONS:Include the following. Other duties may be assigned.Leads development of Environmental Monitoring program qualification through development of risk assessments, protocols, and reports for existing and potential future sample locations and frequencies.Identifies opportunities for continuous improvement and drives changes aimed at enhancing the environmental monitoring program.Authors quarterly and annual environmental monitoring summary reports.Reviews personnel monitoring data, identifying trends that require corrective anizes the review of all environmental documentation.Acts as a hands-on, active leader within the Environmental Technician group and provides knowledge to personnel.Must be able to demonstrate and apply good aseptic technique and cleanroom behavior.Must be able to demonstrate and apply good gowning technique during certification, re-certification, and routine monitoring.Counsels and trains personnel in gowning practices, aseptic technique and proper cleanroom behavior.Must be able to understand the operation and application of all monitoring devices that are automated or manual operation in the department.Must be able to demonstrate the ability to monitor and document all environmental parameters, such as viable sampling, personnel sampling, temperatures, humidity, and differential pressures under static and dynamic conditions.Update sample information in laboratory databases.Particle Measuring System review and interface.Validation protocol testing for new areas and facilities.Ability to assist in performance of thorough investigations related to Environmental MonitoringMust be computer literate, with experience in spreadsheet and database applications.

Created: 2021-11-29