Senior QC Micro Analyst (Shift)

  • Contract
  • Dublin

Website Ref: TPM04304

Summary:
A QC Micro Analyst is required for a biopharmaceutical in South Dublin. This role will support manufacturing operations on a 24/7 shift pattern and may include extended hours.

Responsibilities:

  • Environmental Monitoring of Grade 8/9 Cleanrooms.
  • Environmental Monitoring of Grade 5/7 Cleanrooms & Isolators.
  • Reading of Environmental Monitoring Plates.
  • Bioburden testing of water & disinfectants.
  • Writing technical reports.
  • Utility sampling & testing.
  • Testing of In Process samples such as Protein Concentration, Density & pH.
  • Compressed gas sampling.
  • BI testing.
  • Support QC Specialist with risk assessments/procedures for new facility.
  • Working with the project team to ensure we have sufficient resources and equipment for the project.
  • Completing qualification works for the new isolator, media qualification etc.

Qualifications & Experience:

  • Bachelors degree in a science discipline.
  • Biopharmaceutical QC experience in a microbiology lab.
  • Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
  • Experience working in an aseptic cleanroom performing Environmental Monitoring.
  • Proficient in the use of LIMS & LMES.
  • Technically strong background in microbiology and aseptic manufacturing.
  • Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage.
  • Flexibility – the EM role often encounters changing priorities on a daily basis.
  • Good cross functional communication skills are essential.
  • Presentation skills.
  • Problem solving skills.
  • Experience with Regulatory inspectors and interacting with inspectors desirable.
  • Demonstrated ability to work independently and deliver right first time results.
  • Works under minimal direction.
  • Work is guided by objectives of the department or assignment.
  • Follows procedures.
  • Auditing documentation and operation process.

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.