Job Description Summary

Responsible for performing, scheduling, and/or reviewing microbiology related testing associated with routine testing, customer complaints, validations, and/or projects. Responsible for routine sterilization batch record release and associated sterilization validations.

Bachelor of Science or Arts degree in a scientific field, with a minimum of four courses in microbiology related field- OR - an equivalent level of training, experience, and demonstrated proficiency in understanding and interpreting critical sterilization and microbiological data (minimum of 2 years) is required.

Familiarity and experience with aseptic technique is required.
Familiarity with regulatory environments is preferred.

• Coordinates the activities of the Microbiology Laboratory in support of a 24/7 shift manufacturing operation, and indirectly is responsible for the daily activities of the microbiology lab.
• Supervises the monitoring of inventory of items in the microbiology lab.
• Performs procedures, validation, and training according to Good Manufacturing Practices (GMP) and Corporate Quality Assurance.
• Performs laboratory owned calibrations.
• Understands the principles of scheduling and how it relates to the support the Sterility Assurance Program.
• Schedules and performs non-routine testing as needed.
• Performs out of specification investigations.
• Back up for approving the sterilization dose data with the Senior Microbiologist is absent.
• Coordinates and directs the incubator temperature profiles and the annual laboratory autoclave requalification.
• Assists with the development and documentation associated with new procedures including the development of preventative maintenance programs as needed.
• Responsible for purchasing supplies and maintaining the monthly budget. Assists in the preparation of the annual budget.
• Oversees the training of new associates or the implementation of a new process in the lab. Initiates all technicians to do their jobs and follows up with additional training and instruction as required to maintain satisfactory performance.
• Ability to operate all equipment / perform all testing in the lab with basic trouble shooting skills.
• Performs Lab Technician functions as directed or needed.
• Upholds a high degree of accuracy and good technique in all laboratory procedures, including all testing associated with the support of a Sterility Assurance Program including the preparation of media, mathematical calculations and maintaining records and logbooks. Responsible for reviewing and approving reports, documents and testing that is generated by the Microbiology lab as specified by operating procedures.

• Complies with all local, state, federal and BD safety regulations, policies/procedures.
• Complies with all local BD quality policies/procedures/practices through consistent application of sound Quality Assurance principles.
• Performs other job-related duties as assigned.
• Performs assigned work without continuous supervision.
• Observes all safety, environmental and quality system standards.

• Bachelor of Science or Arts degree in a scientific field, with a minimum of four courses in microbiology related field- OR - an equivalent level of training, experience, and demonstrated proficiency in understanding and interpreting critical sterilization and microbiological data (minimum of 2 years) is required.
• Familiarity and experience with aseptic technique is required.
• Familiarity with regulatory environments is preferred.
• Knowledge of GMP and other regulatory requirements is preferred.
• Familiarity with moist heat and/or gamma irradiation sterilization modalities preferred.