QC Specialist - Microbiology

Job Description

A QC Specialist is required to join the Microbiology team in a global biopharma facility in North Dublin with a state of the art laboratory.

Reporting to the QC Microbiology Manager, the QC Microbiology Specialist 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:

• Performing QC Environmental Monitoring in classified areas including lot related monitoring.
• Utility sampling including WFI, Clean Steam and Compressed Air/Gas.
• Performing Bioburden testing on Utility samples, Drug Substance and Raw Materials within required hold times.
• Performing Bacterial Endotoxin Testing on Utility samples, Drug Substance and Drug Product within required hold times.
• Carrying out In-Process testing of critical lot related samples to support Manufacturing activities.
• Performing Growth Promotion testing of media lots entering the laboratory.
• Carrying out identifications of Microorganisms isolated post testing activities.
• Carrying out the Minute Mouse Virus by PCR for in-process samples.
• 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.

 

Requirements:

• The ideal candidate should hold a minimum of a Level 8 degree in Microbiology or related discipline.
• At least 1 years' experience in a pharmaceutical / healthcare laboratory or related technical function.
• A strong background in Microbiology and aseptic manufacturing is desirable but not essential.
• The successful candidate must demonstrate excellent written and verbal communication skills.
• The ability to work in a team based collaborative environment is essential.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

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