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.
