Location : Waukegan, IL (on-site 5x days)
Duration : 6-month contract to hire
Pay : $28 / hr
Start Date : 10 / 13 / 25
Requirements :
- 1+ years of work experience within a manufacturing environment
- Experience with GMP (Good Manufacturing Practices)
- Attention to detail in relation to sampling techniques
- Experience with environmental monitoring and aseptic technique
- Strong time management skills, communication skills, and critical thinking skills
Plusses :
Familiarity with LIMS or submission of samples to a laboratoryExperience working with aseptic technique within an FDA regulated environmentPast participation in regulatory audits (FDA, ISO, etc)Associate or bachelor’s degree in biology, microbiology, or a science related fieldInsight Global is seeking a detail-oriented and motivated Quality Environmental Monitoring Specialist to join an established medical device company in Waukegan, IL.
Responsibilities :
Perform environmental monitoring of cleanrooms and controlled areas (viable air, non-viable particles, critical surface monitoring, personnel monitoring)Collect routine environmental samples including, but not limited to, surfaces, air, and waterMaintain accurate and complete documentation of the sampling information and results in compliance with Good Documentation Practices (GDP)Label environmental samples appropriately and submit to laboratory via LIMSSubmit finished good products for additional testingReview and perform trending on environmental monitoring resultsHelp with investigations related to out-of-specification (OOS) results, excursions, or contamination eventsAdhere internal quality procedures specifically related to proper gowning, hygiene, and microbial control to maintain cleanliness within cleanroomsAssist in the development and implementation of processes, reports, data analysis, and procedures within the defined area of specializationPerform audits to review all related documentation for completeness, accuracy, and assure the product and reports meets all specifications