Specialist, QC Microbiologist
- Perform routine environmental monitoring, in-process testing and microbiological identifications in accordance with SOPs, safety, and cGMP guidelines to support the release and stability of finished products, raw materials, in-process materials, and various components.ecognize, report, and document deviations from test methodologies, specifications, and alert limits.
- Maintain up to date knowledge of cGMP, job related SOPs and completes all assigned training on time.
- Identify problems with, and offer solutions to, SOPs, records, systems, and procedures.
- Work closely with subject matter experts with regards to discrepancy reporting, investigations and CAPAs associated with the process.
- Develop an awareness of technical advances within the biopharmaceutical industry.
- Knowledge of science generally attained through studies resulting in a B.S., in biological sciences, a related discipline, or its equivalent is preferred.
- A minimum of 4 years experience in a regulated microbiology laboratory.
- Excellent manual dexterity including proficiency in aseptic techniques.
- Proficient with the use of air sampling equipment, autoclaves, micro ID methods, and endotoxin testing.
- Experience requiring one to work independently as well as part of a team, to complete assignments within defined time constraints.
- Knowledge and understanding of cGMP regulations and compendial testing required including sterility and bioburden.
- Demonstrated ability to concurrently conduct multiple routine tasks, procedures, and operations effectively and consistently.