QC Operations Senior Analyst - LIMS Specialist
Ireland Posted 2024-07-19
WuXi Vaccines, a subsidiary of WuXi Biologics, focuses on human vaccine discovery, development and manufacture. An exciting new addition to the WuXi Biologics family, WuXi Vaccines will bring to the global vaccine industry the world-class integrated platforms and CDMO business model on which WuXi Biologics reputation is based. In development is an integrated vaccine manufacturing facility with 240 million US Dollar investment, including drug substance manufacturing (DS), drug product manufacturing (DP), Manufacture Science and Technology Labs (MS&T) as well as Quality Control labs (QC), dedicated to manufacturing our partner's vaccine products for the global market.
Job Summary
The Senior Analyst – LIMS specialist will coordinate all LIMS activities regarding sample management, configurational changes and functionality testing (when required) Other responsibilities will involve senior analytical responsibilities involving equipment maintenance, training and liaising with vendors for bespoke equipment.
Key Responsibilities
* Responsibility for laboratory reagent and consumable management
* Responsibility for sample and standard management
* Control of inventory through LIMS
* Responsible for LIMS configurational updates and site wide communication on sample management / inventory management
* Liaise with local and global IT with LIMS downtime and software updates when applicable
* Coordinate release of laboratory equipment for GMP use
* Coordinate routine maintenance of laboratory equipment
* Review of calibration certificates for laboratory equipment
* Coordinate training in regard to LIMS Admin and User access permissions
* Drafting of technical documents such as SOP, URS and CSV documentation
* Working with vendors to provide additional laboratory support in regard to equipment maintenance and laboratory stock
* Other duties as assigned by the QC operations lead
Education & Experience
* Degree in Pharmacy, Biochemistry, Chemistry or other related scientific or technical discipline
* Previous experience working in a GMP regulated industry
* Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities
* Experience in a Contract Research Organization (CRO) or Contract
* Manufacturing Organization (CMO) is preferred, but not required
* Previous experience with LIMS is essential with MAXIMO and other ERP experience preferred, but not required
* 3-5 years of LIMS inventory / configurational management
* 3+ years LIMS Admin experience within, global experience would be desirable but not essential
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