Über die Tätigkeit
About the Job
The Environmental Specialist will not only act on behalf of the Environmental Supervisor by coordinating monitoring activities, but must also sample as needed, review sampling for completeness and accuracy as needed, and identify any concern areas and trends in cleanroom.
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 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.
- Complete trending reports and analyze data to assist with Deviations and CAPA’s associated with EM and EMS for the Quality Assurance Department. This includes reviewing security videos, interviewing personnel, conducting experiments, and obtaining continued education in the various systems/processes our facility employs.
Ihr Profil
Set Yourself Apart: Profile/Experiences:
- Prefer a degree in Microbiology, Molecular Biology, or related discipline. An equivalent combination of relevant work experience/education is acceptable.
- Have a good understanding of contamination prevention and fundamental understanding of microorganisms.
- Knowledge and understanding of cGMP’s, FDA regulations and industry guidelines.
- Demonstrated leadership skills with the ability to motivate, guide, train, coach and develop department personnel as well as align team members around shared goals.
- Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
- Strong interpersonal skills with the ability to interact with personnel at all management levels in a team environment.
- Ability to respond to challenges and additional projects in an understanding, positive, and objective manner.
- Demonstrate adaptable to dynamic conditions, work practices, and project timelines.
Unser Angebot
Fagron offers exciting opportunities for personal and professional growth, which supports and encourages you to develop your skills and talents. Be part of a collaborative culture that rewards you with competitive compensation, an extensive benefits package and a truly open and dynamic work environment.