With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
The role of the Lead QC Stability Coordinator is to effectively organise and support the site stability programme, site and stability aseptic sampling activities and QC sample management of receipt and delivery of 3rd party samples and sample retains in compliance with ICH, WHO, the company quality guidelines and SOP’s and other regulatory requirements.
Responsible for supervising daily activities of laboratory group to ensure compliance with quality and reliability standards
• Supervises the use of chemical tests and various kinds of measuring instruments in accordance with approved methods and standard operating procedures (SOPs)
• Schedules and communicates with appropriate functional groups regarding status of activities and quality testing requirements
• Provides expert review of data, protocols and reports for adherence to cGMPs and good documentation practices
• Communicates aberrant results and leads investigation to determine root cause
• Ensures quality control training and reviews and approves standard operating procedures (SOPs)
• Coordination of the site stability programme
• Coordinating the receipt of stability samples, reserve samples and retain samples from third party suppliers and store/distribute following site procedures.
Bachelor degree in a relevant scientific discipline (Chemistry, Biology, Biochemistry, etc.)
• 5+ years' quality control experience in the pharmaceutical/biotech/or other regulated industry
• Leadership/ team management skills
• Direct interaction with regulatory agencies
• Knowledge of current Good Manufacturing Practices (cGMP) principles
• Knowledge of FDA and EMA requirements