QC Micro Analyst (shift)

QC Micro Analyst (shift)
RK8629
Contract - 12 months
Cork



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. 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.



Duties:

• 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.

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

• BSc (Honors) in a scientific/technical discipline.
• A minimum of 2 years experience in a QC laboratory-testing environment within the biological and/or pharmaceutical industry.
• Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory