Quality Control Microbiology Specialist

Primary Responsibilities

• Cook up the environmental monitoring (EM) program at both eGenesis manufacturing facilities ensuring the collection, transport and processing of air and surface samples
• Manage the schedule for all routine and non-routine monitoring activities internally and with external contract laboratories
• Perform environmental monitoring sample collection (nonviable, viable, and surface) as well as providing guidance and training on procedures to additional team members
• Keep complete and accurate documentation in electronic test methods
• Review and trend environmental monitoring data
• Support EM and laboratory deviations. Identify and implement corrective actions to prevent reoccurrence
• Author, review, and/or approve data, SOPs, COAs, protocols, reports, deviations, and other quality records
• Work collaboratively with QC contamination control representative and work cross functionally to maintain and enhance cleaning/disinfection program, material/equipment and gowning programs as applicable

Basic Qualifications

• B.S./M.S. in Life Sciences or related field with 0-3 years of experience, in GMP QC Laboratory
• Proficient in microbiology methods (plate enumeration, growth promotion, microbial ID, etc.) and aseptic technique needed to perform EM in a GMP environment
• Strong knowledge of US and EU cGMP regulations/guidance
• The ability to work and lead in a fast-paced environment, manage priorities, and maintain timelines for multiple projects is essential
• Effective communication skills, both verbal and written, at all levels and across various functions