QC Microbiology

Aphex Group; Leinster; On-site; EUR 65,000 - 75,000; Full time

Job summary

Aphex Group, in Ireland, seeks a Senior QC Microbiology specialist to support manufacturing on a 24/7 shift pattern. The role emphasizes environmental monitoring of Grade 8/9 and Grade 5/7 cleanrooms, reading EM plates, and bioburden testing of water and disinfectants, within a cGMP framework.

You will generate technical reports, work with LIMS/LMES, Trackwise and SAP, and interact with regulatory inspectors.

Qualifications

• Biopharmaceutical QC experience in a microbiology lab.
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical product
• Aseptic cleanroom experience for Environmental Monitoring.
• Proficient with LIMS & LMES.
• Strong microbiology and aseptic manufacturing background.
• Experience with regulatory inspectors desirable.
• Ability to deliver right-first-time results.
• Ability to work with changing priorities on a daily basis.

Responsibilities

• 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.
• Testing of In Process samples such as pH.
• Testing of Biological Indicators.

Skills

Microbiology lab experience

Aseptic manufacturing

Independent worker

Regulatory compliance

Environmental monitoring

Tools

LIMS

LMES

Trackwise

SAP

CDOCS

Job description

QC Microbiology (Senior)
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, RABS & Isolators
• Reading of Environmental Monitoring Plates
• Bioburden testing of water & disinfectants
• Writing technical reports such as monthly and annual EM trend reports
• Testing of In Process samples such as pH
• Testing of Biological Indicators

Requirements

• Biopharmaceutical QC experience in a microbiology lab
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical product
• 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
• Experience with Regulatory inspectors and interacting with inspectors desirable
• Demonstrated ability to work independently and deliver right first time results
• 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