QC Microbiologist and Environmental Monitoring Specialist
2 weeks ago
We are seeking a highly skilled QC Microbiologist and Environmental Monitoring Specialist to join our team at Cell Ready. This role will be responsible for overseeing the environmental monitoring and contamination control programs in our GMP facility.
Key Responsibilities- Environmental Monitoring: Perform environmental and personnel monitoring within clean rooms (ISO 5 – ISO 9 environments).
- Laboratory Support: Assist with maintenance of laboratory and media supplies.
- Training and Development: Perform and document training on all laboratory general tasks and is capable of performing assigned test methods with minimal supervision.
- Subject Matter Expertise: Serve as the primary subject matter expert in Microbiology, aseptic processing.
- Gowning Qualification and Training Program: Oversee the Gowning Qualification and Training Program.
- Investigations and CAPAs: Support investigations for environmental excursions and lead investigations to environmental excursions and assists with CAPAs.
- EM Sampling and Trend Reporting: Perform EM sampling for Aseptic Manufacturing Qualifications and assist with data entry and annual EM trend reporting.
- Laboratory Equipment Maintenance: Assist with laboratory equipment upkeep.
- Training and Development: Assist in training of new hires and retraining of QC laboratory staff, as needed.
- Education: Minimum, Associate's degree in biological sciences or related discipline, with 2 years of experience.
- Knowledge and Skills: Demonstrate knowledge in general laboratory skills and microbiological assays, and aseptic test methods. Knowledge of Good Manufacturing Processes (cGMP) and Good Laboratory Practices (GLP). Organizational, multitasking, problem-solving, math, statistical, interpersonal, written and oral communication skills. Detail-oriented and ability to prioritize work.
- Personal Attributes: Team player, do the right thing, even when no one is looking, great listener, accuracy is important, attention-to-detail, reliable, multitasker, critical thinking, strong team and interpersonal communication, quality focus, can work at a fast pace, even tempered, well organized, enjoys learning, conscientious, and always conduct yourself with a high level of professionalism.
- Meaningful Work: You will be an instrumental part of a team that will play a critical role in providing society with widespread access to Cell and Gene Therapies, which many believe is one of the most important advances in the history of cancer treatment.
- Exceptional Compensation: Cell Ready is a well-funded company with no debt, offering a rare combination of meaningful work and exceptional compensation.
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