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** SHIFT - Wed to Sat 7am to 6pm **
Summary
We are seeking a highly motivated individual to join us as a QC Microbiology Technician in our new commercial cell therapy production center located in Frederick, MD. You will work with the Quality Control team in supporting our efforts in this exciting new area of cancer immunotherapy. This position provides Quality Control microbiological testing for clinical and commercial manufactured product, responsible for product testing, microbial growth promotion testing, utility testing and environmental monitoring.
Responsibilities (include but are not limited to):
• Perform environmental monitoring of cleanrooms
• Collect water samples to ensure all sample collected per schedule and tested on time
• Perform and review microbiological assays such as Gram Stain, Endotoxin, Sterility, Microbial Identification, Bioburden and Plate Reading
• Perform utility monitoring of purified water and compress gases
• Data entry and trend data as needed and prepare slides for management
• Assist in investigations regarding out of specifications (OOS) results, address and manage deviations related to micro procedures.
• Routine maintenance of lab equipment and lab spaces
• Review and approve all final product release test results
• Perform other duties as required
Basic Qualifications:
• AA Degree and 1+ years experience in Microbiology lab/Environmental Monitoring OR
• HS Degree and 2+ years experience in Microbiology lab/Environmental Monitoring OR
Preferred Qualifications:
• Experience in the application of microbiological techniques such as environmental air monitoring, water testing, surface monitoring
• Experience in aseptic techniques and clean room operations
• Ability to gown for entry into Aseptic core and supporting areas, and lift approximately 25 lbs.
• Knowledge of GMP, SOPs and quality control processes for commercial manufacturing
• Proficient in MS Word, Excel, Power Point and other applications
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
• Ability to be flexible with schedule, and work overtime as needed
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