Kenny-Whelan (a specialist division of the CPL group) are hiring a QC Specialist - LIMS to work on contract at our clients BioPharma start-up in Limerick
Will consider candidates with expertise in QC Operations, QC Technical services , Senior Analysts. If interested in a role outside bench testing and comfortable with LIMS master data and Comprehensive knowledge of quality control operations
Senior QC LIMS, we are not looking for LIMS Specialists but analysts who will be comfortable working on the LIMS system as its being developed so they will need to be comfortable with data entry as opposed to testing
Additional Information
Organization Overview:
We are designing and building a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site from the ground up. Our new Limerick facility will be one of our most technically advanced manufacturing sites and will include next-gen manufacturing technologies, and advanced data collection and analysis platforms that will result in safety and quality improvements, increased productivity, and variability reduction.
Job Responsibilities:
The key responsibilities of the QC Specialist – LIMS hall include but shall not be limited to:
- Building the content of QCL LIMs systems in collaboration with site and external Digital teams.
- Translating the content of specifications and analytical methods into compliant, effective and efficient LIMs / LES workflows.
- Involved in the qualification of analytical instruments and in their routine maintenance.
- Development of standard operating procedures, specifications and local analytical methods.
-May be involved in reporting results into a computer storage system (LIMS), as well as performing testing using automated systems.
- Involved in deviation investigations and will record any errors encountered, as per procedures and training.
- Assisting in the training of other personnel and as their level of skill develops, may be responsible for the full training of other Laboratory personnel.
Basic Requirements:
- Minimum BSc (Hons) in Analytical Sciences (Chemistry, Biochemistry, Microbiology) with a minimum of 3 years pharmaceutical experience.
- Proficient in the build / use of Laboratory Information Systems. Experience in translating the content of specifications and analytical methods into compliant, effective and efficient LIMs / LES workflows is a distinct advantage.
- Comprehensive knowledge of quality control operations with an emphasis on techniques such as immunoassays, and quantitative PCR, chromatography and capillary electrophoresis separation sciences, spectroscopic techniques.
- Understanding of multiple instrument platforms (e.g. Agilent, Beckman Coulter, Sciex, Molecular Devices, Applied Bioscience, etc.) and associated software applications (e.g. SoftMax Pro, Empower, LIMS / LES systems)
Additional Skills/Preferences:
- Excellent attention to detail in all aspects of the work.
- Demonstrated understanding of Data Integrity and its application in a Digital Laboratory.
- Highly competent with computer systems.
- Demonstrated ability to implement changes in technology and business systems / processes.