Senior/Principal Quality Control Scientist – Microbiologist (Remote)
Requirements
• BS in Microbiology, or other relevant scientific discipline.
• A minimum of 8+ years working experience in a cGMP Quality Control department in an FDA-regulated industry
• Experience in Biopharmaceutical industry required
• Proficiency gained through wide exposure / experience in technical field; broad grasp and application of scientific theory and principles
• Expert working experience with microbiological testing such as membrane filtration and direct plating bioburden, endotoxin testing using kinetic chromogenic systems, microbial identifications and environmental monitoring experience using viable and non-viable methods.
• Strong experience with designing and executing microbial studies and investigations required.
• Strong experience with independent validation of microbial instrumentation required.
• Experience with aseptic technique, TOC and conductivity is required
• Experience with LIMS required
• Ability to perform repetitive tasks while maintaining speed of work and attention to detail.
• Works with other scientists toward achieving goals; information sharing and problem solving requiring monitoring and interpreting data; coordinates or direct others on work efforts
• Expected to conduct projects, evaluate experimental results, provide solutions to problems require choosing from multiple alternatives
• Strong working knowledge of cGMP/ICH/FDA/EMEA regulations and guidelines
• Strong written and oral communication skills
• Ability to identify, investigate, and solve assay and equipment related problems.
• Proficient in MS Office applications; particularly Excel graphing.
• Experience with statistical software such as Minitab© or JMP