Specialist I QA Operations
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!
• Under general supervision, supports quality assurance processes to ensure compliance to current Good Manufacturing Practice (cGMP) regulatory guidelines
• Works with quality assurance staff to ensure inspection and testing procedures are implemented and maintained
• Coordinates and maintains documentation of manufacturing procedures, appropriate specifications, deviations, etc.
• Assures materials meet the applicable requirements following Standard Operating Procedures (SOPs)
• Follows strict cGMP guidelines in assuring material maintains the safety, identity, strength, quality, and purity
• Ensures samples are sent according to schedule, processing rejections and maintaining rejection database
• Assists in the development of standards to meet quality specifications and recommends changes to basic procedures
• Associate's degree in scientific discipline or equivalent vocational or technical training
• 3-5 years' related pharmaceutical experience including experience in a regulated environment
• Knowledge of cGMP standards
• Proficiency in Microsoft Office and QA systems
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.