Quality Control Microbiologist EM

Description

Job Description QC Microbiologist 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 commercial manufactured product, responsible for product testing, utility testing and environmental monitoring. Responsibilities: • Performs environmental and/or utility monitoring and sampling as a primary function. • Performs routine and non-routine inspection of media fill samples (AOQ/APV), collection and/or testing of media, final product, validation-related, and critical utility samples according to SOPs. • Receives, quarantines, and stores purchased microbiological media pending laboratory release. • Monitors bio hazardous waste and coordinates its removal with qualified safety personnel. • Participates in validation and commercial/developmental manufacturing activities. • Reviews and issues Environmental Notifications based on raw data, and validated electronic data acquisition systems. • Represents QC for area of specialization in site meetings. • Supports testing of solid oral dosage, packaging component testing, raw material and sterile product testing. • Troubleshoots standard instrumentation/test methods. • Performs activities in support of final product release testing (e.g. tests applicable for endotoxin, sterility, and particle isolation) and raw material testing (e.g. media growth promotion) where required. • Performs activities in support of environmental monitoring including surface viable air, non-viable air and personnel monitoring. • Performs activities in support of bioburden testing of water and product; and viable/non-viable particles, moisture testing of compressed gases/air

Skills

quality control, microbiology, Environmental Monitoring, Gmp, Cleanroom, Aseptic, Aseptic technique, Bacteria, air sampling, water sampling

Top Skills Details

quality control,microbiology,Environmental Monitoring

Additional Skills & Qualifications

Requirements: • 2+ years of relevant experience and a High School diploma OR BS degree, or degree in related field Qualifications Preferred Requirements: • Prior experience in biopharmaceutical or pharmaceutical industry • Prior lab experience • Basic Knowledge of current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs) on a daily basis. • Basic Knowledge of general Microbiology techniques such as gram staining, aseptic technique, and plate streaking technique. • Knowledge of USP and other regulatory requirements. • Knowledge of HPLC and UPLC systems. • Proficiency in Microsoft Office applications. • Ability to work effectively in a team environment. • Strong verbal, written, and interpersonal communication skills are required. • MODAL/LIMS proficiency. • Technical training on environmental monitoring of facility and utility system.

Experience Level

Intermediate Level