at Fagron Sterile Services in Wichita, Kansas, United States
Job Description
This position will work both independently and with the team to provide oversight of staff training and an in-depth understanding of environmental monitoring of cleanroom as well as sample performance, training, accountability, EMS (Environmental Monitoring System) oversight, CFU (Colony Forming Units) inspection, and overall cleanroom contamination control. In addition, the Environmental Monitoring Lead Technician can conduct investigations associated with monitoring responsibilities as well as be able to assist with internal/external audits.
Key Responsibilities
- Carry out responsibilities in accordance with the organization’s policies, procedures, state, federal, and local laws.
- Understand and provide training on current and upcoming regulatory standards pertaining to Environmental Monitoring and Quality Manufacturing.
- Work cooperatively as an individual contributor and as a team member.
- Communicate effectively with EM personnel, cross-functional peers, and management.
- Assist in troubleshooting issues as they arise as well as performance enhancement opportunities.
- Perform Environmental Monitoring as needed.
- Ensure regulatory and company compliance is maintained.
- Evaluate environmental/personnel monitoring based on an established training course plan.
- Complete and assist with EM deviation investigations.
- Provide direct oversight of processes and personnel completing tasks which includes feedback and coaching.
- Create and maintain workflow that prepares EM technicians for their assigned duties and tasks.
- Recruit and select new hires by attending and participating in interviews.
- Perform all other duties as assigned.
