Biologics Quality Assurance Specialist

5 days ago


County Dublin, Ireland Bms Full time
Job Description

We are seeking a highly skilled QC Microbiology Specialist to join our team at BMS Cruiserath Biologics. The successful candidate will be responsible for supporting Drug Substance and Drug Product site activities related to Environmental Monitoring, Utility sampling, Biological Indicator testing, Media Fill, UV and HPLC in-process testing, and sample processing.

Key Duties and Responsibilities:

  1. Perform cleanroom, BSC & Isolator batch related monitoring
  2. Utility sampling of water systems and Compressed Air/Gas
  3. Carrying out In-Process testing of critical lot related samples to support Manufacturing activities (HPLC and UV Spectrophotometry)
  4. Issuance, receipt, and testing of biological indicators
  5. Reading and reporting of environmental monitoring, BIs, and aseptic qualification sample results
  6. Reconciliation and inspection of media fill units, and participation in media fills
  7. Carrying out identifications of Microorganisms isolated post testing activities
  8. Completing all laboratory documentation in a timely and accurate manner
  9. Compliance with Standard Operating Procedures and Registered Specifications
  10. Assisting in authoring and reviewing documentation
  11. Providing support to other departments to ensure qualification and production schedules are adhered to
  12. Reviewing paperwork, and reconciliation of analysis performed in the laboratory
  13. Ensuring that any alert/action limit excursions are investigated according to site procedures
  14. Receipt and processing of drug substance and drug product samples
  15. Adherence to and improvement upon lean lab and 6S practices
  16. Ensuring a high standard of housekeeping and safety is maintained in the laboratory
  17. Performing any other activities as indicated by the Microbiology Manager


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