QC Microbiologist
San Carlos, CA
We are looking for a driven and talented individual to join our research and development team as we change the future of oncology. While collaborating with cross- functional departments, you will play a key role in maximizing our technology and progressing our novel therapeutics. We are dedicated to making a difference in the lives of patients, both as individuals and as part of a team.
Responsibilities:
- Performs microbiological testing to support the manufacturing facilities and production; testing includes but is not limited to environmental/utilities monitoring, bioburden, growth promotion, microbial limits, endotoxin, microbial identification, and TOC/conductivity testing
- Executes protocols to perform qualification, technology transfer and troubleshooting for microbiology methods/assays
· Reviews environmental monitoring data and laboratory equipment documentation and records
- Supports QC Analytical methods and testing, as needed
- Performs laboratory housekeeping tasks such as equipment cleaning/maintenance and inventory management
- Performs and receives training on microbiological methods
- Interacts with Facilities, Manufacturing and QA as needed to coordinate testing and support adverse events investigations
- Authors and/or approves standard operating procedures (SOPs) for QC Microbiology
- Prepares microbiological reports such as environmental/utilities monitoring and microbial identification
Qualifications:
- 4-year science degree (B.A. or B.S.) with at least 2+ years of hands-on experience in a cGMP environment or master's degree in Microbiology or a related field
- Experience with microbiological testing such as bioburden, endotoxin, growth promotion, Gram stain, and environmental monitoring (total particulates, viable air particulates, and surface monitoring) and utility systems monitoring/testing (bioburden, TOC, conductivity, dew point and oil content)
- Experience working in a Quality Control Environment is preferred
- Ability to communicate clearly, in writing and verbally, with peers, upper management and with external customers
- Strong verbal, written and interpersonal communication with an emphasis on creating a motivated, effective working team
- Understanding of scientific theories, principles, and techniques used in biological and analytical test procedures
- Ability to shift priorities with ease
- Ability to work off-shift, weekends, and holidays, as needed
- Proficient in computer software such as Microsoft Office. Experience with additional software that can be applicable to improving current systems is preferred
- Ability to sit, stand and work within workspace for extended periods of time
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