**MAIN PURPOSE OF ROLE**
The primary function of this position is to perform daily duties of the microbiology laboratory and tests required to monitor the production area environment.
The individual will be responsible for carrying out assigned tasks, which could include laboratory experiments and testing of raw material and processes as per routine documented procedures and to perform the tasks for maintenance of the microbiology laboratory.
**MAIN RESPONSIBILITIES**
- Supporting the Microbiology Laboratory activities:
- General laboratory cleaning (dishwashing, cleaning surfaces, etc.)
- Equipment preparation and sterilization/depyrogenation.
- Material Preparation ( Packaging and sterilization )
- Preparation of special test samples.
- Maintain the necessary testing supplies in stock.
- Ordering and distribution of supplies.
- Preparation of media and Fluids as required.
- Waste disposal as required.
- Perform Test Procedures and Environmental Monitoring
- Perform sterility testing of devices and components.
- Perform bioburden estimation of devices, components, and solutions.
- Collect raw material samples if required.
- Perform identification of microbial isolates.
- Coordinates the predetermined sampling and testing schedule to ensure that the controlled environment rooms and water systems meet the environmental specifications requirements.
- Perform certification testing of cleanrooms according to protocol requirements.
- Ensures that raw materials and finished product requiring testing are sampled and tested.
- Support investigations on out-of specification test results.
- Record Equipment Monitoring Systems.
- Perform and document the Test results (media liquid).
- Validation and Calibration:
- Assists in the validation of the manufacturing sterilizers, the CAE room and supporting systems and the water systems.
- Documentation:
- Maintain and file all laboratory test data and reports.
- Evaluates and maintains trend charts of environmental test data, water system, product tests and other microbiology related data.
- Maintains traceability of clinical product used for testing.
- Level of Review / Authority.
- Test results are reviewed by Microbiologist/Supervisor.
Shift TA