QC Stability Associate

The Stability  Associate   is responsible for   executing  day-to-day  activities to support  stability study   lifecycle s . This role requires a   basic  understanding of stability principles and  has the  ability to   work   well   independently   but under  instruction   and guidance  of the   line manager . The position focuses on preparing  routine  protocols, compiling data,   basic statistical analysis,   and escalating issues promptly.  

Main Responsibilities and Accountabilities  

1   Support   a variety of tasks associated with ongoing stability programs :   

• Able to prepare routine   stability protocols and  compiling   data   throughout study, keeping data tables up to date .  

• Understand different   trends   associated with the data   highlighting to senio r members of the team.  

• Perform basic statistical analysis to support data interpretation and decision-making.  

• Be aware of  pull dates   and associated testing , and which laboratories  are responsible for   conduct ing  the different   test methods .  

• Maintain compliance with GMP, ICH guidelines, and internal procedures.  

• Support investigations into stability-related deviations under guidance.  

• Familiarity with electronic systems ( e.g.   LIMS,  JMP ) for data management.  

2   Provid e  knowledge and understanding :  

• Basic   understanding of stability principles and regulatory expectations.  

• General a wareness of stability-indicating parameters and expected product profiles.  

• Ability to recognize unexpected results and escalate appropriately.  

• Basic knowledge of risk-based assessments and change control processes.  

3   Working collaboratively :  

• Coordinate with QC Operations to monitor  progress   of stability samples.  

• Ensure  routine stability  studies are set up correctly and  data available at all timepoints .  

• Collaborate  well   with colleagues to achieve stability program  objectives .  

• Work effectively,  demonstrating   initiative and accountability.  

4   Competencies:   

Attention to Detail : Ensures accuracy in data compilation and reporting.  

Problem  Recognition : Identifies   issues and escalates promptly.  

Collaboration and Teamwork : Communicates clearly, contributing to a cohesive team environment .  

Learning   Agility : Shows readiness to develop scientific and technical knowledge over time .  

Position Qualifications and Experience Requirements :   

Education Requirements

• Associate degree (Foundation degree HND/HNC or equivalent Level 5 vocational qualification in science related subject essential.   

• Science degree ( e.g.   Bachelor) in pharmacy, pharmaceutical technology, biology,  chemistry   or comparable education   preferred.  

Experience Required  

• 2 + years’ experience in   the pharmaceutical manufacturing industry with direct exposure to Stability program development and management  preferred

• Basic   understanding of product lifecycle management in a global biotech or pharmaceutical GMP environment  

• Awareness   of current regulations and guidelines   of stability monitoring of biopharmaceutical products  

3   Other Essential Knowledge  

• Fluency in English in both writing and oral communications  

Please note - there are 3 positions available for this requisition

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.

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