34204-QC Micro Analyst-Dublin Contractor

This role will support manufacturing operations on a 24/7 shift pattern and may include extended hours.

This is a 12-month initial contract,

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

• Water sampling

• Testing of In Process samples such as Protein Concentration, Density & pH

Qualifications

• Bachelor’s 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

• 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