QC Microbiology Analyst

Life Science Recruitment; Leinster; On-site; EUR 32,000 - 52,000; Full time

Job summary

Life Science Recruitment is assisting an award-winning Pharmaceutical organisation in Dublin to recruit a QC Analyst. You will support general lab readiness and join a GMP environment performing microbiology testing and method transfers.

Responsibilities include environmental monitoring, WFI testing, bioburden and endotoxin testing, data entry in LIMS, maintaining GLP, updating SOPs, training new analysts, calibrating instruments and supporting audits while upholding data integrity and cGMP

Qualifications

• Third level science qualification (Microbiology preferred).
• 1-2 years' relevant experience.
• Experience with analytical microbiology in a GMP setting.

Responsibilities

• Perform routine microbiological analyses including environmental monitoring and endotoxin testing.
• Carry out microbial testing such as WFI testing, bioburden, in-process and final product testing.
• Maintain and complete documentation in LIMS; ensure timely updates.
• Train and be trained in rapid microbiology techniques and SOP adherence.
• Support the lab testing schedule to maintain an efficient QC system.
• Receive, stock and manage laboratory supplies; maintain GLP and cGMP standards.
• Participate in risk assessments, audits and CAPA activities.

Skills

Microbiology

Environmental monitoring

GMP compliance

Documentation

Training others

Data integrity

Quality control

Calibration

Education

Bachelor's degree in Microbiology or related science

Job description

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Key Responsibilities:

• Perform supporting activities for general lab readiness, laboratory equipment qualification and method transfers.


• Perform and carry out a variety of routine microbiological analytical techniques including but not limited to environmental monitoring, WFI testing, growth promotion testing, In-process product testing, Final product testing such as bioburden and both Kinetic turbidmetric and MCS rapid endotoxin testing in compliance with GMP requirements.


• To integrate and complete all documentation on time and be familiar with LIMS.


• To train and be trained in the use of Rapid microbiology techniques including but not limited to endotoxin testing, water bioburden testing, EM testing, absence of bioburden testing and identification testing.


• Follow up-to-date analytical practices with reference to pharmacopoeias, specifications, regulations and industry standards.


• To update SOP’s and write protocols as required.


• Support the laboratory testing schedule to achieve an efficient QC system.


• Receive and manage samples that come into the lab for stability, in-process and release testing.


• Reagent preparation, cleaning, and routine equipment maintenance.


• Maintain good housekeeping and GLP within the laboratory.


• Calibrate and maintain all designated laboratory instruments.


• Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.


• Ensure training is current for all job functions performed.


• Assist in training new QC Analysts on routine procedures and practices.


• Order, stock and receive laboratory supplies.


• Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.


• Ensure that cGMP standards are maintained at all times.

Education and Experience:

• Third Level science qualification (Microbiology is preferred).


• 1 - 2 years' relevant experience.


• Experience with analytical microbiology in a GMP setting.