QC Microbiology Analyst

4 weeks ago

Dublin, Dublin City, Ireland TieTalent Full time
About

QC Microbiology Specialist – Shift Role

Position Summary

We are actively seeking to recruit a QC Microbiology Specialist to become a key member of the Quality Team within a leading Biotech multinational. 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 Responsibilities
  1. Perform cleanroom, BSC & Isolator batch-related monitoring.
  2. Utility sampling of water systems and compressed air/gas.
  3. Carry out in-process testing of critical lot-related samples to support manufacturing activities (HPLC and UV Spectrophotometry).
  4. Issue, receive, and test biological indicators.
  5. Read and report environmental monitoring, BIs, and aseptic qualification sample results.
  6. Reconcile and inspect media fill units, and participate in media fills.
  7. Identify microorganisms isolated post-testing activities.
  8. Complete all laboratory documentation accurately and in a timely manner.
  9. Ensure compliance with Standard Operating Procedures and registered specifications.
  10. Assist in authoring and reviewing documentation.
  11. Support other departments to adhere to qualification and production schedules.
  12. Review paperwork and reconcile analyses performed in the laboratory.
  13. Investigate any alert/action limit excursions according to site procedures.
  14. Process drug substance and drug product samples.
  15. Qualifications and Experience: Hold a minimum of a Level 8 degree in Microbiology or related discipline. At least 2 years' experience in a pharmaceutical or healthcare laboratory or related technical function. Experience working in a cleanroom environment using aseptic techniques is required; experience with isolators is advantageous. Experience with HPLC and UV Spectrophotometry is desirable but not essential. Familiarity with MODA, Empower, CIMS, LIMS, LES, and Veeva Vault is desirable but not essential. Must demonstrate excellent written and verbal communication skills and the ability to work collaboratively in a team environment.
Additional Information

For more information, contact Nicola at (phone number removed) or email your CV in confidence to (email address removed).

Location

Dublin, Ireland

Work Experience
  • HR
  • Healthcare
Languages
  • English
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