Environmental Monitoring Specialist

2 weeks ago


Pleasant Prairie, Wisconsin, United States Medasource Full time

Position Overview: Environmental Monitoring Specialist

Company: Medasource

Location: Pleasant Prairie, WI

Shift: First Shift; Non-exempt

Key Responsibilities:

The Environmental Monitoring Specialist will play a crucial role in supporting Parenteral Operations by executing environmental assessments within classified manufacturing zones. This includes:

  • Conducting environmental monitoring to ensure compliance with industry standards.
  • Performing utility sampling and analysis to uphold quality assurance.
  • Assisting in the training of Quality Control - Microbiology personnel.
  • Providing operational support during routine monitoring and sampling activities.

Essential Objectives:

Adhere to and advocate for compliance with all current Good Manufacturing Practices (cGMP), Quality Systems, and Good Laboratory Practices (GLP). Key deliverables include:

  • Executing environmental monitoring in accordance with established protocols.
  • Supporting laboratory operations through effective utility sampling and analysis.
  • Managing routine laboratory maintenance and inventory effectively.
  • Facilitating technical training and mentorship for QC-Microbiology Technicians.
  • Engaging in continuous improvement initiatives within the department.
  • Assisting in the development of Standard Operating Procedures (SOPs) and Work Instructions.

Qualifications:

Education: A Bachelor's degree in Microbiology or a related discipline is required; an Associate's degree or High School Diploma may be considered based on experience.

Experience: A minimum of 2 years of relevant experience in environmental monitoring within a GMP Pharmaceutical Manufacturing environment is essential. Experience should include:

  • Proficiency in environmental monitoring techniques such as viable surface monitoring and air quality assessments.
  • Experience with compressed air monitoring and water sampling.

Preferred Skills:

Familiarity with cGMP regulations and compliance requirements in a manufacturing setting is advantageous. Strong interpersonal skills and the ability to communicate effectively with colleagues and management are essential. Candidates should be comfortable working in a laboratory environment, including the use of personal protective equipment (PPE) and cleanroom attire as necessary.

Additional Information:

Minimal travel (approximately 10%) may be required for training purposes. The role involves regular physical activity, including standing and walking for extended periods, and the ability to lift weights between 15 to 25 pounds. The position requires flexibility in working hours to support ongoing operations.

This job description provides a general overview of the responsibilities and qualifications for the Environmental Monitoring Specialist position. Responsibilities may evolve over time, and employees are encouraged to consult with their supervisors regarding specific duties.



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