Entity: CSL Seqirus
Job Category: Quality
Job Family: Quality Control
Job Type: Full Time
Location: Liverpool, Merseyside, United Kingdom
Employer Reference: R-280773
Core Activities
- Expertise in setting up studies, preparing protocols, compiling data, and generating detailed stability reports.
- Perform approvals of protocols and reports.
- Lead compilation, interpretation, and presentation of stability data.
- Perform statistical analysis and data extrapolation to support decision-making.
- Train Stability Scientists in technical and knowledge-based aspects.
- Support lower-level regulatory requests and provide necessary documentation.
- Coordinate with QC Operations to ensure timely sample pulls, testing, and data entry into LIMS.
- Conduct risk-based assessments in collaboration with Principal Stability Scientist.
- Lead more complex investigations into stability-related deviations and propose corrective actions.
- Lead and manage multiple stability projects concurrently, ensuring alignment with business priorities and regulatory obligations.
- Ensure compliance with GMP, ICH guidelines, and internal standards.
- Skilled in using electronic systems (e.g. LIMS, JMP) for data management.
Knowledge and Understanding
- High level of understanding of regulatory requirements and stability principles.
- Comprehensive knowledge of product stability profiles and key indicators.
- Ability to lead investigations and provide technical guidance.
- Good product knowledge and understanding of expected profiles
- Experienced in risk-based assessments and change control processes.
Working collaboratively
- Deliver global stability activities and ensure timely execution.
- Coordinate with QC Operations to monitor progress of stability samples.
- Proactively identify and resolve issues impacting stability programs.
- Work effectively with limited supervision, demonstrating initiative and accountability, and providing support for others in the team as necessary.
- Ability to support multiple projects, directing team members supporting the projects and delivering goals and milestones on time.
CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
