Quality Control Microbiologist

The Quality Control Microbiology Technician plays an essential role in maintaining the quality, safety, and compliance of our manufacturing environment. This position supports the Environmental Monitoring Program
, evaluates and trends environmental data, documents deviations, and performs approved microbiological testing within an ISO Class 8 cleanroom environment
.

In addition to microbiology responsibilities, the Technician will support key Quality Control activities, including incoming materials management, label control, cleaning validation/verification, and contamination-related investigations
.

This is an excellent opportunity for a detail-oriented laboratory professional who enjoys working in a regulated manufacturing environment and takes pride in maintaining high standards of quality and compliance.

• Routinely monitor temperature, pressure, and humidity within production areas using air samplers, growth/media plates, environmental sensors, and applicable software systems.
• Perform environmental monitoring activities using appropriate aseptic techniques while properly donning and maintaining required personal protective equipment (PPE).
• Collect samples and document results associated with third-party laboratory testing
  , including environmental monitoring plates, endotoxin testing, and quarterly inspection testing.
• Perform sampling activities supporting cleaning validations and verifications
  .
• Develop clear and informative charts, graphs, and trend reports for presentation to cleanroom personnel and Asteria Health Operations and Quality teams on a monthly basis.
• Identify and report out-of-specification (OOS) test results to management in accordance with established procedures.
• Support the review and improvement of microbiological procedures, including recommendations for SOP revisions and change controls based on observations and test results.
• Assist with non-conformance investigations, deviations, and Corrective and Preventive Actions (CAPA) related to contamination and environmental monitoring.
• Support training and qualification activities for personnel performing environmental monitoring in accordance with approved SOPs and Work Instructions
  .
• Serve as a role model for proper gowning and cleanroom practices for personnel working in ISO Class 8 areas.

• Maintain accurate inventory records and document the receipt of incoming materials and supplies used for testing.
• Prepare and organize required documentation, specifications, and supporting records for incoming material approval
  .
• Properly label, segregate, and store approved materials in accordance with applicable regulations, company policies, and procedures.
• Support the overall integrity and accuracy of Quality Control documentation and records.

• Print product labels in accordance with documented specifications for each product and production lot.
• Perform routine cleaning, inspection, and maintenance of the product label printer.
• Accurately document labeling activities within production batch records.
• Maintain proper segregation and control of labels for distinct production lots.
• Coordinate with Production and Operations to ensure labels are appropriately issued and controlled for their respective lots.

• Continued education in Biology, Microbiology, or a related scientific field
  , plus approximately two years of experience working in a laboratory or cleanroom environment.
• Equivalent combinations of education and experience may be considered, including approximately two years of experience in a microbiology laboratory or environmental monitoring program within a cleanroom.
• Working knowledge and practical experience with current Good Manufacturing…