QC Microbiology Analyst - Contract - Biopharmaceutical
In a state-of-the-art bio facility in Dublin, we are seeking a QC Microbiology Analyst to support the Bulk Drug Facility with microbiological testing such as Environmental Monitoring, Water, Gas, Bioburden and Endotoxin testing.
Responsibilities:
* Conduct microbiological testing, including Environmental Monitoring and Water sampling, testing of Bioburden, Endotoxin, TOC, and provide technical support for method validation.
* Maintain high cGMP, GLP standards during testing.
* Represent the Microbiology department in internal and external audits as required.
* Perform technical review of laboratory data, validation protocols, and reports.
* Evaluate the functionality of instruments and equipment and ensure they are calibrated and operational.
* Maintain a high standard of housekeeping and safety in the Laboratory.
* Analyze out-of-specification/limit results using Structured Problem Solving and Root Cause Analysis tools under the guidance of the Microbiology Laboratory Supervisor.
Requirements:
* A minimum of 1 year's experience in a cGMP Quality environment.
* Experience in testing sterile/non-sterile pharmaceutical/bio-pharmaceutical products.
* Good knowledge of current GMP and other industry regulations.
* A degree in Microbiology or a related science.