QC Microbiology Technician I

Job Description

Job 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.

Duties and Responsibilities:

• 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, Growth Promotion, Bioburden and Plate Reading.
• Perform and review visual inspection of final product.
• 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.

Education and Experience:

• AA Degree and 1+ years’ experience in Microbiology lab/Environmental Monitoring.
• HS Degree and 2+ years’ experience in Microbiology lab/Environmental Monitoring.
• Experience in the application of microbiological techniques such as environmental air monitoring, water testing, surface monitoring.
• Experience in aseptic techniques and clean room operations.

Knowledge, Skills and Abilities:

• Ability to gown for entry into Aseptic core and supporting areas, and lift approximately 25 lbs.
• Ability to pass vision exam for visual inspection.
• 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.