Specialist, QC Microbiology

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The Role 

BMS Cruiserath Biologics is seeking to recruit a QC Microbiology Analyst within the QC Microbiology Laboratory. Reporting to the QC Microbiology Manger, the QC Microbiology Analyst will be responsible for supporting site activities related to Product Testing and Environmental/Utility Monitoring, performing testing of samples and laboratory duties in accordance with cGMP regulations. 

Responsibilities will include (but not limited to): 

• Performing Sterility testing on Drug Product samples.

• Performing Bacterial Endotoxin Testing on Drug Product, Drug Substance, Raw Material and Utility samples within required hold times. 

• Performing Bioburden testing on Drug Substance, Raw Materials and Utility samples within required hold times.  

• Performing Growth Promotion testing of media lots entering the laboratory. 

• Carrying out identifications of Microorganisms isolated post testing activities. 

• Performing QC Environmental Monitoring in classified areas including lot related monitoring. 

• Utility sampling including WFI, Clean Steam and Compressed Air/Gas. 

• Carrying out In-Process testing of critical lot related samples to support Manufacturing activities. 

• Carrying out the Minute Mouse Virus by PCR for in-process samples. 

• Performing compendial verification, method transfer/validation, and routine testing of in-process, drug substance and drug product samples in accordance with applicable procedures and cGMP requirements. 

• Completing all laboratory documentation in a timely and accurate manner. 

• Compliance with Standard Operating Procedures and Registered Specifications. 

• Assisting in authoring and reviewing documentation, including SOPs. 

• Providing support to other departments to ensure qualification and production schedules are adhered to. 

• Reviewing Batch paperwork, and reconciliation of analysis performed in the laboratory. 

• Ensuring that any alert/action limit excursions are investigated according to site procedures. 

• Ensuring a high standard of housekeeping and safety is maintained in the laboratory. 

• Performing any other activities as indicated by the Microbiology Manager. 

Qualifications and Experi