MedImmune QC Stability Analyst in Liverpool, United Kingdom
Title: QC Stability Analyst
Location: Liverpool, UK
If you’re inspired by the possibilities science holds to change lives, and thrive when making brave decisions then join us.
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease.
We are currently seeking a talented individual who has a passion for Stability. The QC Stability Analyst role involves providing expert technical and analytical support to the Quality Control function and Site including stability study management, investigations, and understanding and using Laboratory information management system (GQCLIMS). The individual should be dynamic with an analytical mindset. The QC Stability Analyst will be responsible working collaboratively with cross functional teams to devise new stability studies and their analysis. The individual should be qualified to graduate level/or equivalent in a scientific discipline, with experience of working with GQCLIMS.
Some of the responsibilities include:
Inventory and equipment management of ongoing clinical and commercial stability programs
Writes and execution of protocols and reports
Builds stability studies within GQCLIMS system
Review and monitor stability trending data on a regular basis
Provide support to maintain cGMP testing in support of stability out of specifications (OOS) investigations and Non-conformance investigations.
Delivering training and coaching to the testing Analysts within the QC group for stability GQCLIMS.
Authors stability sections of regulatory documents and submissions.
To be successful in this position, you will need to have the following background:
Successful applicant will have a minimum of a BSc or equivalent in a related scientific discipline or experience.
Experience in stability function and preferably GQCLIMS experience
Understanding of Quality Control testing function.
Good organizational and communication skills
Sound knowledge and understanding of the principles and concepts of compliance management and Good Manufacturing Practice / Good Laboratory Practice
Opening date: 17th July 2017
Closing date: 20th August 2017
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.