- Dublin North
- JN -012024-1954225
- Jan 18, 2024
QC Microbiology Analyst preferably with 1 -2 years industry experience required to join a global bio-pharmaceutical company.
Responsibilities will include:
- Performing bioburden testing on utility samples, drug substance and raw materials within the required hold times.
- Performing bacterial endotoxin testing on utility samples, drug substance and drug product within the required hold times.
- Carrying out the Minute Mouse Virus (MMV) by PCR and quantitative PCR (qPCR) testing of in-process samples.
- Perform 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.
- Performing growth promotion testing of media and organism lots entering the laboratory.
- Performing microbial identifications using MALDI-TOF and MicroSEQ.
- 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 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 manufacturing is desirable but not essential.
- The successful candidate must demonstrate excellent written and verbal communication skills.
- The ability to work in s team.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
- Consultant | Life Sciences & Engineering Recruitment