Job Description
QC Operations Analyst role at WuXi Vaccines, a subsidiary of WuXi Biologics, involves supporting Quality Control department operations, managing laboratory reagents and consumables, and coordinating equipment maintenance.
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.
The QC Operations Analyst will report into the Quality Control Operations Lead and support all operational activities within our Quality Control department. Key responsibilities include:
- Responsibility for laboratory reagent and consumables management
- Responsibility for sample and standard management
- Control of inventory through LIMS
- Coordinate release of laboratory equipment for GMP use
- Coordinate routine maintenance of laboratory equipment
- Review of calibration certificates for laboratory equipment
- Drafting of technical documents such as SOP, URS
- Working with vendors to provide additional laboratory support in regard to equipment maintenance and laboratory stock
Education and experience requirements include:
- Advanced degree (Bachelor, Master or PhD) in Pharmacy, Biochemistry, Chemistry or other related scientific or technical discipline
- Previous experience working in a GMP regulated industry
- Comfortable in a fast-paced 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, Trackwise, 5-S, Maximo is preferred, but not required