QC Microbiology Analyst

I am recruiting for a QC Microbiology Analyst to join a leading biopharmaceutical company located in North Dublin. The analyst 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.

Qualifications 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, 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.