Contract Quality Control, Microbiologist

Neogene is searching for a highly motivated Contract QC Microbiologist who will be responsible for compendial and rapid microbiology laboratory methods, serves as the technical lead for evaluation, validation, and implementation of new microbiology methods and EM program. This individual will work closely with functional technical operation teams supporting the organizational vision. This role is based in Santa Monica, CA and reports to Director of Quality.

Responsibilities

• Conduct investigations regarding environmental monitoring (EM) action level excursions, and out of specifications (OOS) results for microbiological testing.
• Author, review and execute SOPs, Protocols, Reports relating to GMP microbiology processes, test methods and related equipment maintenance Participate and support regulator audits
• Perform other related duties and responsibilities as assigned.
• Oversight of microbiology programs such as growth promotion, bioburden, BacT/ALERT rapid sterility, compendial sterility, and endotoxin methods.
• Implement, maintain, and oversee environmental monitoring program, personnel monitoring, trending and analysis
• Oversee and perform the day-to-day activities related to Environmental Monitoring, product release testing, and contamination control.

Requirements

• Must have demonstrated experience analyzing and interpreting technical results and summarizing these results in technical reports.
• Demonstrated knowledge of regulatory guidance and industry best practices
• Expert knowledge and understanding of Microbiology principles, theories, concepts and laboratory methodologies.
• Strong knowledge of aseptic manufacturing and EM processes
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Master's Degree in a related science plus 4+ years of GXP experience in the biotech and/or pharmaceutical industry specific to microbial contamination and controls OR Bachelor's Degree in a related science and 6+ years of GXP experience in the biotech and/or pharmaceutical industry specific to microbial contamination and controls
• Must demonstrate effective organizational skills and ability to manage multiple projects.
• Strong knowledge and experience in several of the following areas of competency: aseptic processing, clean room and contamination control, environmental monitoring microbiological methods and cleaning validation.