Thermo Fisher Scientific QA Technician, Environmental and Utilities Monitoring in Lenexa, Kansas
QA Technician, Environmental Monitoring and Utility Testing
The QA Technician will implement the environmental monitoring program, including qualification and periodic confirmation of manufacturing environments and utility systems.
Perform sampling to ensure environment and utilities meet ISO standards and regulatory requirements as applicable.
Set, incubate, and read microbial media test results.
Track, trend, and present test results.
Maintain SOPs and Forms for environmental monitoring and utility testing.
Perform annual review of alert levels.
Initiate deviation investigations for test results exceeding alert and action levels.
Perform investigations when abnormal results are found.
Support Regulatory and Customer Audits.
Support continuous improvement activities and participate in lean activities.
High School Diploma or equivalent.
Experience in manufacturing or laboratory setting.
Availability to work alternate shifts when needed.
1+ years of quality assurance or laboratory experience in a regulated environment such as medical device, pharmaceutical, or food manufacturing.
Strong working knowledge of quality related tools, such as structured problem solving, FMEA (Failure Mode and Effects Analysis), SPC (Statistical Process Control), DOE (Design of Experiments).
Experience in Medical device, cGMP, or ISO certified environment.
Data analysis skills and ability to utilize computer programs to analyze data.
Ability to schedule tasks to ensure completion according to schedule.
Demonstrated ability to work effectively as a member of a cross-functional team.
Strong working knowledge of various computer software, such as Excel.
Experienced with lean manufacturing tools and practices.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.