Quality Control Technician, Environmental Monitoring (Evening Shift)
On-siteElwood, Kansas, United States
Job Summary
Perform routine and non-routine environmental monitoring (air and surface sampling) and utility testing (WFI, USP water, pure steam, and clean compressed air) to ensure manufacturing environments meet strict quality standards. Conduct complex microbiology-based analysis on raw materials, in-process samples, and final products, including endotoxin, bioburden, TOC/Conductivity, and sterility testing. Provide critical production support by participating in aseptic process simulations and production fills while maintaining gown qualification. Lead laboratory stewardship activities, including growth promotion of culture media, microbial identification, equipment calibration support, and maintaining meticulous inventory and safety standards. Support site quality systems by assisting in OOS/OOT investigations, drafting and revising SOPs, and preparing method validation protocols and analytical study reports. This role requires a High School Diploma or GED with five years of relevant experience, or a Bachelor's degree in Microbiology, Biological Sciences, or Pharmaceutical Sciences. Shift hours are 5pm to 1:30 am Monday through Friday in Elwood, KS.
Required Qualifications
- High School Diploma or GED
- 5 years of relevant experience
- Bachelor's degree in Microbiology, Biological Sciences, Pharmaceutical Sciences, or a closely related field
- Demonstrated experience in a laboratory or technical environment with a focus on microbiology
- Advanced technical proficiency in aseptic technique and sterile gowning
- Excellent organizational and documentation skills
- Ability to succeed in a physically demanding role that requires long hours on your feet and the movement of heavy laboratory materials
- Availability for evening shift hours (5pm - 1:30 am Mon-Fri)
Desired Qualifications
- Prior experience in a cGMP-regulated environment
- Specialized knowledge of FDA, USDA, and ISO requirements for pharmaceutical or veterinary biologics
- Proven expertise in sterility testing
- Proven expertise in mycoplasma analysis
- Proven expertise in water system monitoring
- Experience with analytical method development
- Experience with validation protocols
- Experience with the use of specialized instrument software to obtain results
- Strong technical writing skills for the creation of quality procedures and investigation reports
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