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QC Stability Associate
- Liverpool, England, United Kingdom
- Liverpool, England, United Kingdom
À propos
The StabilityAssociateis responsible forexecutingday-to-dayactivities to supportstability studylifecycles. This role requires abasicunderstanding of stability principles andhas theability toworkwellindependentlybut underinstructionand guidanceof theline manager. The position focuses on preparingroutineprotocols, compiling data,basic statistical analysis,and escalating issues promptly.
Main Responsibilities and Accountabilities
1Supporta variety of tasks associated with ongoing stability programs:
Able to prepare routinestability protocols andcompilingdatathroughout study, keeping data tables up to date.
Understand differenttrendsassociated with the datahighlighting to senior members of the team.
Perform basic statistical analysis to support data interpretation and decision-making.
Be aware ofpull datesand associated testing, and which laboratoriesare responsible forconductingthe differenttest 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.
2Provideknowledge and understanding:
Basicunderstanding 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.
3Working collaboratively:
Coordinate with QC Operations to monitorprogressof stability samples.
Ensureroutine stabilitystudies are set up correctly anddata available at all timepoints.
Collaboratewellwith colleagues to achieve stability programobjectives.
Work effectively,demonstratinginitiative and accountability.
4Competencies:
Attention to Detail:Ensures accuracy in data compilation and reporting.
ProblemRecognition:Identifiesissues and escalates promptly.
Collaboration and Teamwork:Communicates clearly, contributing to a cohesive team environment.
LearningAgility: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,chemistryor comparable educationpreferred.
Experience Required
2+ years’ experience inthe pharmaceutical manufacturing industry with direct exposure to Stability program development and management preferred
Basicunderstanding of product lifecycle management in a global biotech or pharmaceutical GMP environment
Awarenessof current regulations and guidelinesof 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.
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
Compétences linguistiques
- English
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