Job Descriptions

Key responsibilities for this role include:

• The analysis finished product for Bacterial Endotoxin and Sterility.  
• Ensure that all microbiology laboratory operations are carried out in compliance with EHS, cGMP and regulatory commitments.
• Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations
• Perform laboratory investigations to determine root cause and implementation of appropriate corrective and preventative action.
• Creation and revision of training material for the Sterility, Bacterial endotoxin and microbiological techniques.
• Review of analytical data
• Knowledge and experience in some or all the following is an advantage, Bacterial endotoxin, Sterility, Growth promotion for media, Environment monitoring and Isolators
• Promote and participate in the implementation and maintenance of relevant safety programmes.
• Demonstrate a proactive approach towards Continuous Improvement

The minimum qualifications for this role are:

• BSc in Science or equivalent qualification
• 1-3 years relevant experience working with a variety of aseptic and Microbiological  techniques in a GMP laboratory within the biological and/or pharmaceutical industry.
• Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory
• Good working knowledge of QC Systems, LIMS and Trackwise is an advantage
• Excellent communication skills
• Work with minimal supervision; able to perform under pressure to competing demands and stakeholders; strong customer focus
• Continuous improvement mindset
• Positive, can-do attitude

Skills

Experience

• 1-3 years