Our Quality Operations group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

Specific to Environmental and Utility Monitoring, the analyst will be responsible for maintaining the EM program to include the following:

• Collection and testing of qualified Utility systems including Clean Steam, WFI, and compressed gases.
• Execute environmental sampling of Classified Areas including active air sampling, surface sampling, and non-viable air sampling.
• Provide data entry, review and approval as required.
• Provide summaries of test results to appropriate personnel as needed.
• Compile and evaluate environmental data for adverse trends.
• Directly support Performance Qualification activities.
• Perform routine monitoring of Personnel. - Compile and author Annual Reviews.
• Author and summarize Re-qualification, Performance Qualification, and Special Study protocols.
• Perform monthly and weekly sample accountability.
• Submit LIMS sample rejections. - Equipment Calibration and Management
• Filing data sheets and document control of logbooks - Other duties requested by Management.
• In addition, the candidate selected for the Environmental Monitoring (EM) position will be responsible for reading EM Plates, TOC analysis, Conductivity, Gas Testing, LIMS, SAP, Trackwise, Investigations with GMP experience.

Education Minimum Requirement:

• Associate’s degree preferably in a science field

Required Experience and Skills:

• At least 1 year of relevant experience
• Ability to work 4 10-hr shifts (Sun - Wed) 4p - 2:30a or Wed-Sat 4p - 2:30a.

Preferred Experience and Skills:

• EM Sampling in a pharmaceutical setting (not EPA) with GMP experience
• Quality Control, Quality Assurance and/or cGMP experience