Specialist/Sr. Specialist QC (Analytical Science & Technology)
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!
Reporting to the Analytical Science and Technology Sr. Manager in Holly Springs. The role is accountable for Quality Control method validation lifecycle management, method development and method standardization/robustness. The validation specialist is an SME in testing methodology, able to troubleshoot technical issues, develop current and existing methods and be current with the latest analytical testing technologies. The role requires the execution of intra site method transfers and SME input into regulatory filings/audits and investigations. Responsible for experimental design on key projects that involve new technologies and processes to QC. The employee is required to review data generated from validation activities and bring to the attention of Management any detrimental trend or deviation identified.Major Accountabilities:
- Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written
- Participates preventive action & continuous improvement programs to reduce operating costs
- Leads cross-training to support staff availability within QC department
- Owns, develops, and maintains methods and GSOPs
- Subject matter expert in assigned assays/techniques
- Writes applicable protocols and reports
- Leads method transfers, validations and verifications
- Owns/authors deviation and invalid assay assessments
- Performs peer review of data as required
- Plans and schedules routine operations with QC
- Attends project related meetings as departmental representation as required
- Participation in quality risk assessments
Bachelor’s degree in related scientific field
6+ years of laboratory experience OR 6+ years with advanced degree OR equivalent related to Virology
Experience within virology lab
Knowledge of GMPs, safety regulations and data integrity
Knowledge of method validation and transfer with in depth understanding of requirements, preferably related to Virology
Ability to communicate technical knowledge