QC Analysts Pharma Bioassay
This is a great opportunity to join an expanding Biologics site here in Cork. Working in a dynamic and fast paced environment you`ll be 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. On offer is a fixed term contract on a competitive salary and benefits package. About the Job: Well versed 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 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. About You: 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. Good working knowledge of Bioburden, Endotoxin, Environmental Monitoring, Microbial Identification, ELIZA testing and qPCR testing required. Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory. Good knowledge of LIMS, Track wise and Electronic documentations systems. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.
157 days ago