QC Micro Analyst

Morgan McKinley; Dublin; On-site; EUR 42,000 - 65,000; Full time

Job summary

Morgan McKinley is seeking a qualified Biopharmaceutical QC professional in the Dublin area to perform environmental monitoring across Grade 5–9 cleanrooms, read EM plates, and conduct bioburden testing of water and disinfectants. You will write monthly and annual EM trend reports and sample in-process materials such as pH.

Strong microbiology background and aseptic manufacturing experience are essential. The role requires reading EM plates, interacting with regulatory inspectors when needed,

Qualifications

• Bachelor's degree in science required.
• Biopharmaceutical QC experience in a microbiology lab.
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.

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

Skills

Microbiology expertise

Aseptic manufacturing

Problem solving

Independent work

Communication skills

Regulatory inspection experience

Education

Bachelor's degree in a science discipline

Tools

LIMS

LMES

Trackwise

SAP

CDOCS

Change Control

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