QC Stability Associate

CSL
7 hours ago
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The Stability Associate is responsible for executing day-to-day activities to support stability study lifecycles. 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 senior 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 conducting 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 Provide knowledge and understanding: 

  • Basic understanding of stability principles and regulatory expectations. 

  • General awareness 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

About CSL Seqirus

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/.

 

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

 

You Belong at 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

 

Equal Opportunity Employer

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.

Watch our ‘On the Front Line’ video to learn more about CSL Seqirus

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