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QC Micro Analyst

Posted 1 day 4 hours ago by Morgan McKinley

Permanent
Not Specified
Other
Dublin, Ireland
Job Description
Specific Job Duties:

  • Environmental Monitoring of Grade 8/9 Cleanrooms

  • Environmental Monitoring of Grade 5/7 Cleanrooms, RABS & Isolators

  • Reading of Environmental Monitoring Plates

  • Bioburden testing of water & disinfectants

  • Writing technical reports such as monthly and annual EM trend reports

  • Water sampling

  • Testing of In Process samples such as pH

  • Testing of Biological Indicators


Basic Qualifications

  • 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


Preferred Qualifications

  • Experience working in an aseptic cleanroom performing Environmental Monitoring

  • Proficient in the use of LIMS & LMES


Competencies

  • 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

  • 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, GxP and DI practices.

  • Refers to technical standards, principles, theories and precedents as needed

  • May set project timeframes and priorities based on project objectives and ongoing assignments.

  • Recognizes and escalates problems

  • Demonstrated leadership and communication skills

  • Auditing documentation and operation process

  • Demonstrated ability to interact with regulatory agencies

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