Associate QC Micro (24/7)
Associate QC Micro (24/7)
Ireland - Dun Laoghaire Apply Now
JOB ID:
R-239830
País:
Ireland - Dun Laoghaire
Estado:
On Site
DATE POSTED:
Mar. 24, 2026
CATEGORÍA DE EMPLEO:
Quality
This role will support manufacturing operations on a 24/7 shift pattern and may include extended hours.
Specific Job Duties:
- 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
- Water sampling
- Testing of In Process samples such as pH
- Initiate and/or implement changes in controlled documents.
- Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
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
- Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
- Biopharmaceutical QC experience in a microbiology lab
- Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
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
- 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
- Auditing documentation and operation process
- Demonstrated ability to interact with regulatory agencies.