• Quality Environmental Monitoring Specialist

    Insight Global (Waukegan, IL)


    Job Description

    Insight 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 water

     

    Maintain 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 LIMS

     

    Submit finished good products for additional testing

     

    Review and perform trending on environmental monitoring results

     

    Help with investigations related to out-of-specification (OOS) results, excursions, or contamination events

     

    Adhere internal quality procedures specifically related to proper gowning, hygiene, and microbial control to maintain cleanliness within cleanrooms

     

    Assist in the development and implementation of processes, reports, data analysis, and procedures within the defined area of specialization

     

    Perform audits to review all related documentation for completeness, accuracy, and assure the product and reports meets all specifications

     

    We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

     

    Skills and 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 Familiarity with LIMS or submission of samples to a laboratory

     

    Experience working with aseptic technique within an FDA regulated environment

     

    Past participation in regulatory audits (FDA, ISO, etc)

     

    Associate or bachelor’s degree in biology, microbiology, or a science related field