Under the supervision of the Quality Manager, the Sterility Testing Associate will perform testing to confirm the sterility of PharMEDium compounded preparations. The Sterility Testing Technician will process samples of compounded preparations for sterility testing per PharMEDium Standard Operating Procedures. Familiarity with Microbiology procedures including a clean room atmosphere is required. PRIMARY DUTIES AND RESPONSIBILITIES:
Qualifications: EXPERIENCE AND EDUCATIONAL REQUIREMENTS: MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:
- Performs tasks using aseptic technique in a Laminar Airflow Clean Bench.
- Performs functions essential to the maintenance of laboratory equipment. This would include documentation of quality control functions in accordance with PharMEDium Standard Operating Procedures.
- Performs and documents results of sterility tests conducted by the Rapid Sterility Testing Laboratory and all associated support activities.
- Responsible for ensuring adequate supplies are available to support testing. This would include ordering supplies.
- Identifies and recognizes â€œout of specâ€ conditions and responds accordingly by immediately notifying Quality Management and participates in additional testing, completing investigations, and implementing corrective actions.
- Observe all safety, environmental and quality system standards.
- Maintains the cleanliness of the testing area and general laboratory.
- Must perform all other duties and responsibilities as determined by the Quality Manager.
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