QC Microbiology Specialist
Dublin 15- 8 month contract- must have minimum stamp 1G visa valid until end of 2025
Reporting to the QC Microbiology Manager, the QC Microbiology Specialist will be responsible for supporting Drug Substance and Drug Product site activities related to Bioburden and Endotoxin in-process testing and sample processing.
Key Duties and Responsibilities
• Carrying out In-Process testing of critical lot related samples to support Manufacturing activities.
• 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.
• 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.
• 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.
• Providing support to other departments to ensure qualification and production schedules are adhered to.
• Reviewing paperwork, and reconciliation of analysis performed in the laboratory.
• Ensuring that any alert/action limit excursions are investigated according to site procedures.
• Adherence to and improvement upon lean lab and 6S practices.
• Ensuring a high standard of housekeeping and safety is maintained in the laboratory.
• Performing any other activities as indicated by the Microbiology Manager.
Qualification, Knowledge and Experience
• 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 technique is desirable but not essential.
• Sterility experience is desirable but not essential.
• Experience in Bioburden and Endotoxin testing is desirable but not essential.
• Experience using MODA, Empower, CIMS, LIMS, LES and Veeva Vault 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.
Note: This candidate may be required to work a shift pattern.
