Job Description
Job Description:
- Working with the Quality Control team in supporting our efforts – 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.
- 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
Basic Qualifications:
- AA Degree and 1+ years’ experience in Microbiology lab/Environmental Monitoring OR
- AA 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.
- 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