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 HR@insightglobal.com.To 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/.
Required Skills & Experience
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
Nice to Have Skills & Experience
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
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.