QC Microbiology (Sterility)

Microbial Testing:

• Conduct routine microbial testing of raw materials, in-process components, and finished products.
• Perform microbial identification, enumeration, and viability testing using appropriate methods.
• Execute environmental monitoring and testing in production areas.

Media Preparation and Sterility Testing:

• Prepare microbiological media and reagents according to established procedures.
• Perform sterility testing on products and components as required.
• Maintain aseptic techniques during laboratory work.

Documentation:

• Maintain detailed and accurate records of microbiological testing and results.
• Generate microbiology reports summarizing test data and trends.
• Document and report any microbial deviations or contamination events.

Sampling and Environmental Monitoring:

• Develop and implement sampling plans for materials, products, and environments.
• Collect samples for microbial analysis in accordance with established procedures.
• Monitor cleanrooms and manufacturing areas for microbial contamination.

Method Validation and Verification:

• Participate in the validation and verification of microbiological test methods.
• Ensure that test methods are accurate, reliable, and compliant with regulatory standards.
• Collaborate with the validation team for equipment and method validation.