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The QC Microbiology Associate will be responsible for performing environmental monitoring, personnel monitoring, and microbiological testing to ensure compliance with industry standards and regulations. The successful candidate will work closely with the Quality Control team to support the production process and ensure product quality.  Additionally, this position supports on-site activities related to sample management.

RESPONSIBILITIES:

• Conduct environmental monitoring of controlled areas (e.g., clean rooms).

• Collect samples from non-viable air, viable air (active and passive), surface monitoring, and personnel

monitoring to support routine environmental monitoring, in-process environmental monitoring, process

simulation, aseptic operator qualification and gowning qualification.

• Performs sampling and testing of GMP utilities such as compressed gases.

• Perform microbiological testing.

• Ensure all tests are completed in accordance with SOPs and regulatory guidelines.

• Conduct routine cleaning and maintenance of laboratory equipment to ensure optimal performance.

• Keep detailed records of equipment maintenance activities and schedules.

• Generate work orders for equipment servicing and repairs, as needed.

• Ensure laboratory cleanliness and compliance with safety standards.

• Properly handles, stores, and disposes of hazardous materials according to site procedures.

• Coordinates the shipping of isolates for microbial identification

• Performs any combination of sample management tasks, including label, prepare for shipping, transfer to

labs, inventory, and disposal.