Your new role:
This position is responsible for carrying out tasks and projects related to raw material, utility, in process, release and stability testing of biotechnology products as required by Good Manufacturing Practice (GMP).

The Microbiology Team supports all Micro QC testing across the whole Company sites.
They are a Launch and Grow site, so they have routine and non-routine testing that supports batch release, projects and more.
They two main test methods are Bioburden and Endotoxin.
They also process environmental monitoring plates, perform plate reading and several chemistry tests such as TOC, Conductivity, pH, nitrates, and appearance.

General Responsibilities:

• Achieves a high level of competency in laboratory methods and procedures to support raw material, utility, in process, release and stability testing of biotechnology products.
• Performs routine and non-routine Microbiological and or Biochemical/Chemical testing activities as required.
• Ensures that all testing is completed, reviewed and approved within agreed turnaround times.
• Ensures QC activities are carried out in compliance with product license commitments, cGMP and company quality standards.
• Trains other QC analysts and Manufacturing personnel in laboratory methods and procedures when required.
• Writes/updates and reviews TMs, SOPs and WIs as required.
• Writes and reviews invalid assays, non-conformances and deviations as required.
• Initiates and drives change controls to completion to implement process improvements.
• Actively participates in JBIL lean initiatives such as Kaizen, 5S and Gemba.
• Is an active member of the QC group and provide assistance with other group activities as required.
• Communicates relevant issues to the QC Team Leader promptly.

Other responsibilities/ duties may occur:

• Deputises for the QC Team Leader as appropriate.
• Maintains and develops knowledge of analytical technology as well as cGMP standards.
• Partners with other departments to ensure that all QC testing activities are completed in a compliant and efficient manner

What you'll need to succeed:
Testing experience (preferred but can be learned):

• Initiation and Maintenance of Mammalian Cell Lines
• Cell Culture Based Bioactivity Testing
• ELIZA Testing
• qPCR Testing
• Bioburden
• Endotoxin
• Environmental Monitoring
• Microbial Identification

Qualifications and Experience:

• BSc (Honors) in a scientific/technical discipline.
• Experience in a QC/ Micro laboratory-testing environment within the biological and/or pharmaceutical industry.
• Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1106659